#Recurrent C. diff. Prevention Clinical Trial
Explore tagged Tumblr posts
cdifffoundation · 8 years ago
Text
Rebiotix Reports Topline Results From a Controlled Open-label Phase 2 Trial of RBX2660 (PUNCH™ Open Label) For the Prevention of Recurrent Clostridium difficile (C. diff.) Infection (rCDI)
Rebiotix Reports Topline Results From a Controlled Open-label Phase 2 Trial of RBX2660 (PUNCH™ Open Label) For the Prevention of Recurrent Clostridium difficile (C. diff.) Infection (rCDI)
In The News
April 2017
    Rebiotix Inc., a clinical-stage microbiome company focused on harnessing the power of the human microbiome to treat challenging diseases, today announced topline results from a controlled open-label Phase 2 trial of RBX2660 (PUNCH™ Open Label) for the prevention of recurrent Clostridium difficile (C. diff.) infection.
Data indicated that RBX2660 was well-tolerated and…
View On WordPress
0 notes
pharmaphorumuk · 5 years ago
Text
PureTech’s Vedanta Biosciences gets federal funding for C. Diff. microbiome therapy
Tumblr media
US biotech Vedanta Biosciences has been awarded up to $76.9 million to develop VE303 for high-risk Clostridioides difficile (C. diff.) infection by a US government agency.
The Biomedical Advanced Research and Development Agency (BARDA) will pay $7.4 million up front, plus payments worth up to $69.5 million if the project is successful.
Vedanta is one of PureTech’s stable of companies and this is the first ever BARDA award in the microbiome field.
Funding will support completion of an ongoing phase 2 trial and further clinical development of VE303, an orally-administered live biotherapeutic product (LBP) consisting of eight bacterial strains designed to therapeutically reset a patient’s gut microbiota to stop C. Diff infection.
The product is made from pure, clonal bacterial cell banks, which yield a standardised drug product in powdered form, and could replace the need for faecal transplants and the process of having to find donors.
Products such as this aim to repopulate the gut with harmless bacteria that are resistant against pathogenic bacteria such as C. diff., which can take hold in a patient’s digestive tract after treatment with antiobiotics.
While there are no approved competitors, Ferring Pharma reported positive results from a phase 3 trial of its RBX2660 earlier this year, and other firms working in this area include UK-based Microbiota, working in partnership with Roche.
Vedanta’s ongoing phase 2 study is a multi-centre, randomised, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of two doses of VE303 compared to placebo in patients with high-risk C. diff. infection.
The study is enrolling patients with a recent confirmed diagnosis of C. Diff. infection who have completed a course of antibiotics but remain at high risk for recurrence. The primary endpoint is prevention of infection recurrence at eight weeks.
Vedanta was founded by PureTech and a global team of scientific co-founders who have expertise in the cross-talk between the microbiome and the immune system.
The post PureTech’s Vedanta Biosciences gets federal funding for C. Diff. microbiome therapy appeared first on .
from https://pharmaphorum.com/news/puretechs-vedanta-biosciences-gets-federal-funding-for-c-diff-microbiome-therapy/
0 notes
paullassiterca · 6 years ago
Text
Super Poopers: Premium Donors Sought for Fecal Transplants
Fecal microbiota transplants (FMTs) have become increasingly popular to cure diarrheal infections, including Clostridium difficile (C-diff). Unfortunately, after the media carried encouraging research results, many began following advice given on YouTube channels to do their own fecal transplants.
Although a fairly common medical practice, performing your own transplant exposes you to a range of bacteria that may do more harm than good. Donor feces obtained from medical facilities are first screened and tested for microbes having previously been associated with health conditions such as Parkinson’s and multiple sclerosis, before being used in transplant procedures.1
Physicians have reported patients experiencing sudden weight gain or new bowel diseases after fecal transplants. Even those who appear to be in robust health may silently carry harmful bacteria they can pass to others.
Fecal transplants have become a standard of care for those suffering repeated infections with C-diff and physicians can now prescribe freeze-dried donor stool in capsule form that their patients can swallow.2
A new study published in Frontiers in Cellular and Infection Microbiology3 supports the theory that some fecal donors have gut bacteria that increases the success rate in treating disease over the average donor. Called “super donors,” the study finds results of clinical remission may double with super donor stool compared to stool from the average donor.
Fecal Transplants From Super Donors Increase Success Rates
Since Alzheimer’s, multiple sclerosis, asthma, heart disease and certain cancers are associated with changes to gut bacteria, researchers were interested in understanding what makes a fecal super donor. Senior study author Justin O'Sullivan, Ph.D., from the University of Auckland, says:4
“The last two decades have seen a growing list of medical conditions associated with changes in the microbiome — bacteria, viruses and fungi, especially in the gut.
In fact, we know already that changes to the gut microbiome can contribute to disease, based on studies in germ-free mice as well as clinical improvement in human patients following restoration of the gut microbiome by transplanting stool from a healthy donor.”
The efficacy of FMT in treating chronic diseases has been modest, with scientists and doctors finding high variability in patient responses. Some studies have pointed to the microbial diversity and composition of the donor, believing this increases the potential of a super donor.
In this new study, the researchers reviewed evidence and explored the idea that keystone bacterial species may be predictors of FMT success. O'Sullivan and the team analyzed more than 100 fecal transplant trials, finding evidence that not only do super donors exist, but data that could potentially explain why.5
In the small percentage who outperformed others, the donors had a high diversity of microbiota. These results may be significant in helping to identify how human gut microbiology influences disease to develop screening for FMT donors.
Today, the overall cure rate for recurrent diarrhea infections exceeds 90 percent. However, FMT for other conditions has an average success rate of only 20 percent.6 O'Sullivan believes the pattern of success actually demonstrates the existence of super donors, where clinical remission rates may double over those of the average donor.
One Stool Doesn’t Fit All Conditions
Researchers have also found the balance of other bacteria present in the stool sample, and the interactions between them, influence the retention of species needed to treat specific conditions.7 By digging deeper, researchers discovered not only do the species of bacteria matter, but also what’s present around the bacteria, such as viruses and other debris.
Ultimately, the team acknowledges the bacterial diversity of super donors may not fully account for successful transplantation, as some failures could be attributed to the recipient’s immune response to the transplanted microbes, potentially stemming from underlying genetic differences.8
Compatibility between the donor and recipient, in which bacterial species and strains are present in the recipients’ gut before transplant, are also important in predicting success.
O'Sullivan believes supporting the transplanted microbiome through diet is important to improving the success rate, as it has been shown a rapid change in diet can alter the composition of your gut microbiota within 24 hours.9 The researchers concluded that while super donors may be identified as those whose donations have a higher potential for success, there is no “one stool fits all.”
The authors believe FMT will require a personalized approach with better matching between recipients and donors to improve transplant success. Through improved matching, the procedure may also have a higher rate of success for other diseases, such as asthma. Robert Knight, Ph.D., expert on human microbiome from UC San Diego, who was not involved in the study, commented:10
“Strategies to find super-donors whose stool is especially effective as a curative are still in their infancy, although progress on this topic — or making synthetic super-donors from the stool of many people — could greatly improve application of [fecal transplants].”
FMT Helps Re-Establish Bacteria Wiped Out by Chemotherapy
Your gut microbiome exists in a dynamic balance between external and internal stimuli. Anything impacting the balance, such as chemotherapy and antibiotics, can severely change your gut microbiota. Chemotherapy-induced cognitive impairment and mucositis are common side effects of chemotherapy treatment for cancer.11 
Two studies from Memorial Sloan-Kettering investigated how gut microbiome influences the outcome for patients undergoing stem cell transplants. The data revealed changes in the balance of bacteria affect the patient receiving a treatment for blood cancers, such as leukemia and lymphoma, making them temporarily more susceptible to infection.
Antibiotics used to prevent or treat some infections following the transplant also create an opportunity for harmful antibiotic-resistant bacteria to grow abundantly in the gastrointestinal tract. Researchers found a diversity of bacteria can substantially drop with the administration of chemotherapy and antibiotics, increasing the likelihood infections in the bloodstream.12
A second study demonstrated graft-versus-host disease is also affected by the balance of microbiota and the gut.13 The goal of a recent study published in Scientific Reports14 was to assess the efficacy of FMT to reverse antibiotic and chemotherapy-induced dysbiosis in an animal model.
Ampicillin was administered to mice causing a significant and immediate decrease in bacterial species richness and diversity, persisting for one week. However, in the mice receiving FMT, the disruption was reversed immediately.
The mice who received FMT demonstrated significant increase in bacterial species known to have anti-inflammatory properties. While chemotherapy led to a critical decrease in beneficial bacteria, FMT appeared to mitigate these effects.
Stool Donation Not as Simple as It Sounds
If you’re considering donating stool, it may not be as simple as it sounds. OpenBiome is a Boston-based company aimed at expanding the safety and access to FMT. They actively recruit stool donors and pay up to $40 per donation, but carefully screen applicants.
The company claims an 85 percent success rate for treatment for C-diff using their FMT. In order to donate, individuals must be from the Boston area and pass a series of rigorous screenings.15 Applicants must be between 18 and 50 years old during their donation period, go through a clinical in-person health assessment and two rounds of blood and stool testing.
After this rigorous screening, only 3 percent of applicants are accepted. The nonprofit’s clinical program director states this is because most of the chosen stool will eventually end up treating a recipient and if not carefully screened the recipient could wind up with a number of medical conditions.16
Donors who have taken antibiotics, traveled anywhere deemed risky, or if their body mass index or alcohol intake is too high, are not accepted. Once they pass the initial questionnaire, a clinician asks up to 200 more questions on other topics such as a history of depression, anxiety, allergies and asthma, some of the other common reasons a donor may be ruled out.17
Once accepted, donors can provide samples three times a week for a period of 60 days, earning approximately $40 for each donation. At the end of 60 days, if they wish to continue providing donations, they must go through the screening process again.18
Protect and Improve Your Gut Microbiome Using These Simple Steps
Hippocrates once said “all disease begins in the gut,” and the more we learn, the more accurate that statement becomes. With research and study, scientists now understand your gut plays a crucial role in many health and disease processes, and actually acts as your body’s second brain.
The diversity of your gut is established as an infant and affected by genetics, whether you’re breast or bottle-fed and your immediate environment. As you age, it is continually affected by your food choices and medications. Diets high in sugar and processed foods reduce the variety and have a negative impact on your overall health.
Taking care of your gut not only may help prevent disease, but also may help you achieve your goals in weight loss, fitness and overall health and wellness. The consequences of a poorly developed microbiome may affect your mood, emotions, allergies and anxiety.19
Consider these strategies to improve your gut microbiome and affect recovery should you have to take antibiotics.
• Eat more fermented foods — This is one of the easiest, most effective and least expensive ways to make a significant impact on your gut microbiome. Fermentation, especially when using a starter culture, ensures you end up with a high-quality product with high levels of healthy bacteria and beneficial enzymes, including short-chain fatty acids that support healthy immune function.
• Take probiotics and prebiotics — Probiotics increase the diversity of your microbiome, while prebiotics feed beneficial bacteria, helping them to grow and thrive. Beneficial bacteria require high levels of fiber found in a variety of fruits and vegetables.20
If you starve your gut microbiome of fiber, some die off and others switch their source of nutrients to the mucus lining your gut.21 High-fiber diets help reduce your risk of premature death from all causes,22 but in order to work the fiber must be unprocessed.23 Processed supplement fiber such as inulin powder does not provide your gut bacteria what they need.
It’s far better to use a supplement processed from Jerusalem artichokes where inulin is extracted. Organic whole husk psyllium is another great source, as are sunflower sprouts and fermented vegetables, the latter of which also supply beneficial bacteria.
• Avoid antibiotics — Before antibiotics, the average life expectancy was 47 years and most died from communicable diseases. Today the leading causes of death are noncommunicable, but antibiotics are triggering other health conditions. Although useful in severe infections, they also damage bacterial colonies in your gut, which may increase your risk for a number of different ailments and diseases.
If it is essential to take antibiotics, sporebiotics may be able to re-establish your gut microbiome more effectively than regular probiotics when taken in conjunction with antibiotics, as they do not contain any live strains, only spores.
• Avoid processed foods — Processed foods are high in sugar and grains and low in fiber. I believe you need 50 grams of fiber for every 1,000 calories consumed each day, as fiber feeds your good bacteria and strengthens your gut health.
Sugar is the preferred fuel for harmful bacteria, so it’s important to reduce your net carbohydrate intake and eliminate processed foods and white sugar.
• Optimize your vitamin D — Optimizing your vitamin D level to 60 to 80 ng/mL is another simple yet effective means of improving your gut microbiome and reducing metabolic syndrome. Vitamin D deficiency is associated with the development of certain cancers, infections, cardiovascular disease and dysbiosis.24 In one study, researchers discovered metabolic syndrome in mice improved when supplemented with vitamin D.25
An insufficient amount of vitamin D aggravated the imbalance in the gut microbiota. This finding confirms vitamin D deficiency hinders the production of antimicrobial molecules your body uses to maintain the integrity of gut bacteria.26
from Articles http://articles.mercola.com/sites/articles/archive/2019/02/04/fecal-microbiota-transplantation.aspx source https://niapurenaturecom.tumblr.com/post/182545686636
0 notes
jakehglover · 6 years ago
Text
Super Poopers: Premium Donors Sought for Fecal Transplants
Fecal microbiota transplants (FMTs) have become increasingly popular to cure diarrheal infections, including Clostridium difficile (C-diff). Unfortunately, after the media carried encouraging research results, many began following advice given on YouTube channels to do their own fecal transplants.
Although a fairly common medical practice, performing your own transplant exposes you to a range of bacteria that may do more harm than good. Donor feces obtained from medical facilities are first screened and tested for microbes having previously been associated with health conditions such as Parkinson's and multiple sclerosis, before being used in transplant procedures.1
Physicians have reported patients experiencing sudden weight gain or new bowel diseases after fecal transplants. Even those who appear to be in robust health may silently carry harmful bacteria they can pass to others.
Fecal transplants have become a standard of care for those suffering repeated infections with C-diff and physicians can now prescribe freeze-dried donor stool in capsule form that their patients can swallow.2
A new study published in Frontiers in Cellular and Infection Microbiology3 supports the theory that some fecal donors have gut bacteria that increases the success rate in treating disease over the average donor. Called "super donors," the study finds results of clinical remission may double with super donor stool compared to stool from the average donor.
Fecal Transplants From Super Donors Increase Success Rates
Since Alzheimer's, multiple sclerosis, asthma, heart disease and certain cancers are associated with changes to gut bacteria, researchers were interested in understanding what makes a fecal super donor. Senior study author Justin O'Sullivan, Ph.D., from the University of Auckland, says:4
"The last two decades have seen a growing list of medical conditions associated with changes in the microbiome — bacteria, viruses and fungi, especially in the gut.
In fact, we know already that changes to the gut microbiome can contribute to disease, based on studies in germ-free mice as well as clinical improvement in human patients following restoration of the gut microbiome by transplanting stool from a healthy donor."
The efficacy of FMT in treating chronic diseases has been modest, with scientists and doctors finding high variability in patient responses. Some studies have pointed to the microbial diversity and composition of the donor, believing this increases the potential of a super donor.
In this new study, the researchers reviewed evidence and explored the idea that keystone bacterial species may be predictors of FMT success. O'Sullivan and the team analyzed more than 100 fecal transplant trials, finding evidence that not only do super donors exist, but data that could potentially explain why.5
In the small percentage who outperformed others, the donors had a high diversity of microbiota. These results may be significant in helping to identify how human gut microbiology influences disease to develop screening for FMT donors.
Today, the overall cure rate for recurrent diarrhea infections exceeds 90 percent. However, FMT for other conditions has an average success rate of only 20 percent.6 O'Sullivan believes the pattern of success actually demonstrates the existence of super donors, where clinical remission rates may double over those of the average donor.
One Stool Doesn't Fit All Conditions
Researchers have also found the balance of other bacteria present in the stool sample, and the interactions between them, influence the retention of species needed to treat specific conditions.7 By digging deeper, researchers discovered not only do the species of bacteria matter, but also what's present around the bacteria, such as viruses and other debris.
Ultimately, the team acknowledges the bacterial diversity of super donors may not fully account for successful transplantation, as some failures could be attributed to the recipient's immune response to the transplanted microbes, potentially stemming from underlying genetic differences.8
Compatibility between the donor and recipient, in which bacterial species and strains are present in the recipients' gut before transplant, are also important in predicting success.
O'Sullivan believes supporting the transplanted microbiome through diet is important to improving the success rate, as it has been shown a rapid change in diet can alter the composition of your gut microbiota within 24 hours.9 The researchers concluded that while super donors may be identified as those whose donations have a higher potential for success, there is no "one stool fits all."
The authors believe FMT will require a personalized approach with better matching between recipients and donors to improve transplant success. Through improved matching, the procedure may also have a higher rate of success for other diseases, such as asthma. Robert Knight, Ph.D., expert on human microbiome from UC San Diego, who was not involved in the study, commented:10
"Strategies to find super-donors whose stool is especially effective as a curative are still in their infancy, although progress on this topic — or making synthetic super-donors from the stool of many people — could greatly improve application of [fecal transplants]."
FMT Helps Re-Establish Bacteria Wiped Out by Chemotherapy
Your gut microbiome exists in a dynamic balance between external and internal stimuli. Anything impacting the balance, such as chemotherapy and antibiotics, can severely change your gut microbiota. Chemotherapy-induced cognitive impairment and mucositis are common side effects of chemotherapy treatment for cancer.11 
Two studies from Memorial Sloan-Kettering investigated how gut microbiome influences the outcome for patients undergoing stem cell transplants. The data revealed changes in the balance of bacteria affect the patient receiving a treatment for blood cancers, such as leukemia and lymphoma, making them temporarily more susceptible to infection.
Antibiotics used to prevent or treat some infections following the transplant also create an opportunity for harmful antibiotic-resistant bacteria to grow abundantly in the gastrointestinal tract. Researchers found a diversity of bacteria can substantially drop with the administration of chemotherapy and antibiotics, increasing the likelihood infections in the bloodstream.12
A second study demonstrated graft-versus-host disease is also affected by the balance of microbiota and the gut.13 The goal of a recent study published in Scientific Reports14 was to assess the efficacy of FMT to reverse antibiotic and chemotherapy-induced dysbiosis in an animal model.
Ampicillin was administered to mice causing a significant and immediate decrease in bacterial species richness and diversity, persisting for one week. However, in the mice receiving FMT, the disruption was reversed immediately.
The mice who received FMT demonstrated significant increase in bacterial species known to have anti-inflammatory properties. While chemotherapy led to a critical decrease in beneficial bacteria, FMT appeared to mitigate these effects.
Stool Donation Not as Simple as It Sounds
If you're considering donating stool, it may not be as simple as it sounds. OpenBiome is a Boston-based company aimed at expanding the safety and access to FMT. They actively recruit stool donors and pay up to $40 per donation, but carefully screen applicants.
The company claims an 85 percent success rate for treatment for C-diff using their FMT. In order to donate, individuals must be from the Boston area and pass a series of rigorous screenings.15 Applicants must be between 18 and 50 years old during their donation period, go through a clinical in-person health assessment and two rounds of blood and stool testing.
After this rigorous screening, only 3 percent of applicants are accepted. The nonprofit's clinical program director states this is because most of the chosen stool will eventually end up treating a recipient and if not carefully screened the recipient could wind up with a number of medical conditions.16
Donors who have taken antibiotics, traveled anywhere deemed risky, or if their body mass index or alcohol intake is too high, are not accepted. Once they pass the initial questionnaire, a clinician asks up to 200 more questions on other topics such as a history of depression, anxiety, allergies and asthma, some of the other common reasons a donor may be ruled out.17
Once accepted, donors can provide samples three times a week for a period of 60 days, earning approximately $40 for each donation. At the end of 60 days, if they wish to continue providing donations, they must go through the screening process again.18
Protect and Improve Your Gut Microbiome Using These Simple Steps
Hippocrates once said "all disease begins in the gut," and the more we learn, the more accurate that statement becomes. With research and study, scientists now understand your gut plays a crucial role in many health and disease processes, and actually acts as your body's second brain.
The diversity of your gut is established as an infant and affected by genetics, whether you're breast or bottle-fed and your immediate environment. As you age, it is continually affected by your food choices and medications. Diets high in sugar and processed foods reduce the variety and have a negative impact on your overall health.
Taking care of your gut not only may help prevent disease, but also may help you achieve your goals in weight loss, fitness and overall health and wellness. The consequences of a poorly developed microbiome may affect your mood, emotions, allergies and anxiety.19
Consider these strategies to improve your gut microbiome and affect recovery should you have to take antibiotics.
• Eat more fermented foods — This is one of the easiest, most effective and least expensive ways to make a significant impact on your gut microbiome. Fermentation, especially when using a starter culture, ensures you end up with a high-quality product with high levels of healthy bacteria and beneficial enzymes, including short-chain fatty acids that support healthy immune function.
• Take probiotics and prebiotics — Probiotics increase the diversity of your microbiome, while prebiotics feed beneficial bacteria, helping them to grow and thrive. Beneficial bacteria require high levels of fiber found in a variety of fruits and vegetables.20
If you starve your gut microbiome of fiber, some die off and others switch their source of nutrients to the mucus lining your gut.21 High-fiber diets help reduce your risk of premature death from all causes,22 but in order to work the fiber must be unprocessed.23 Processed supplement fiber such as inulin powder does not provide your gut bacteria what they need.
It's far better to use a supplement processed from Jerusalem artichokes where inulin is extracted. Organic whole husk psyllium is another great source, as are sunflower sprouts and fermented vegetables, the latter of which also supply beneficial bacteria.
• Avoid antibiotics — Before antibiotics, the average life expectancy was 47 years and most died from communicable diseases. Today the leading causes of death are noncommunicable, but antibiotics are triggering other health conditions. Although useful in severe infections, they also damage bacterial colonies in your gut, which may increase your risk for a number of different ailments and diseases.
If it is essential to take antibiotics, sporebiotics may be able to re-establish your gut microbiome more effectively than regular probiotics when taken in conjunction with antibiotics, as they do not contain any live strains, only spores.
• Avoid processed foods — Processed foods are high in sugar and grains and low in fiber. I believe you need 50 grams of fiber for every 1,000 calories consumed each day, as fiber feeds your good bacteria and strengthens your gut health.
Sugar is the preferred fuel for harmful bacteria, so it's important to reduce your net carbohydrate intake and eliminate processed foods and white sugar.
• Optimize your vitamin D — Optimizing your vitamin D level to 60 to 80 ng/mL is another simple yet effective means of improving your gut microbiome and reducing metabolic syndrome. Vitamin D deficiency is associated with the development of certain cancers, infections, cardiovascular disease and dysbiosis.24 In one study, researchers discovered metabolic syndrome in mice improved when supplemented with vitamin D.25
An insufficient amount of vitamin D aggravated the imbalance in the gut microbiota. This finding confirms vitamin D deficiency hinders the production of antimicrobial molecules your body uses to maintain the integrity of gut bacteria.26
from HealthyLife via Jake Glover on Inoreader http://articles.mercola.com/sites/articles/archive/2019/02/04/fecal-microbiota-transplantation.aspx
0 notes
jerrytackettca · 6 years ago
Text
Super Poopers: Premium Donors Sought for Fecal Transplants
Fecal microbiota transplants (FMTs) have become increasingly popular to cure diarrheal infections, including Clostridium difficile (C-diff). Unfortunately, after the media carried encouraging research results, many began following advice given on YouTube channels to do their own fecal transplants.
Although a fairly common medical practice, performing your own transplant exposes you to a range of bacteria that may do more harm than good. Donor feces obtained from medical facilities are first screened and tested for microbes having previously been associated with health conditions such as Parkinson's and multiple sclerosis, before being used in transplant procedures.1
Physicians have reported patients experiencing sudden weight gain or new bowel diseases after fecal transplants. Even those who appear to be in robust health may silently carry harmful bacteria they can pass to others.
Fecal transplants have become a standard of care for those suffering repeated infections with C-diff and physicians can now prescribe freeze-dried donor stool in capsule form that their patients can swallow.2
A new study published in Frontiers in Cellular and Infection Microbiology3 supports the theory that some fecal donors have gut bacteria that increases the success rate in treating disease over the average donor. Called "super donors," the study finds results of clinical remission may double with super donor stool compared to stool from the average donor.
Fecal Transplants From Super Donors Increase Success Rates
Since Alzheimer's, multiple sclerosis, asthma, heart disease and certain cancers are associated with changes to gut bacteria, researchers were interested in understanding what makes a fecal super donor. Senior study author Justin O'Sullivan, Ph.D., from the University of Auckland, says:4
"The last two decades have seen a growing list of medical conditions associated with changes in the microbiome — bacteria, viruses and fungi, especially in the gut.
In fact, we know already that changes to the gut microbiome can contribute to disease, based on studies in germ-free mice as well as clinical improvement in human patients following restoration of the gut microbiome by transplanting stool from a healthy donor."
The efficacy of FMT in treating chronic diseases has been modest, with scientists and doctors finding high variability in patient responses. Some studies have pointed to the microbial diversity and composition of the donor, believing this increases the potential of a super donor.
In this new study, the researchers reviewed evidence and explored the idea that keystone bacterial species may be predictors of FMT success. O'Sullivan and the team analyzed more than 100 fecal transplant trials, finding evidence that not only do super donors exist, but data that could potentially explain why.5
In the small percentage who outperformed others, the donors had a high diversity of microbiota. These results may be significant in helping to identify how human gut microbiology influences disease to develop screening for FMT donors.
Today, the overall cure rate for recurrent diarrhea infections exceeds 90 percent. However, FMT for other conditions has an average success rate of only 20 percent.6 O'Sullivan believes the pattern of success actually demonstrates the existence of super donors, where clinical remission rates may double over those of the average donor.
One Stool Doesn't Fit All Conditions
Researchers have also found the balance of other bacteria present in the stool sample, and the interactions between them, influence the retention of species needed to treat specific conditions.7 By digging deeper, researchers discovered not only do the species of bacteria matter, but also what's present around the bacteria, such as viruses and other debris.
Ultimately, the team acknowledges the bacterial diversity of super donors may not fully account for successful transplantation, as some failures could be attributed to the recipient's immune response to the transplanted microbes, potentially stemming from underlying genetic differences.8
Compatibility between the donor and recipient, in which bacterial species and strains are present in the recipients' gut before transplant, are also important in predicting success.
O'Sullivan believes supporting the transplanted microbiome through diet is important to improving the success rate, as it has been shown a rapid change in diet can alter the composition of your gut microbiota within 24 hours.9 The researchers concluded that while super donors may be identified as those whose donations have a higher potential for success, there is no "one stool fits all."
The authors believe FMT will require a personalized approach with better matching between recipients and donors to improve transplant success. Through improved matching, the procedure may also have a higher rate of success for other diseases, such as asthma. Robert Knight, Ph.D., expert on human microbiome from UC San Diego, who was not involved in the study, commented:10
"Strategies to find super-donors whose stool is especially effective as a curative are still in their infancy, although progress on this topic — or making synthetic super-donors from the stool of many people — could greatly improve application of [fecal transplants]."
FMT Helps Re-Establish Bacteria Wiped Out by Chemotherapy
Your gut microbiome exists in a dynamic balance between external and internal stimuli. Anything impacting the balance, such as chemotherapy and antibiotics, can severely change your gut microbiota. Chemotherapy-induced cognitive impairment and mucositis are common side effects of chemotherapy treatment for cancer.11 
Two studies from Memorial Sloan-Kettering investigated how gut microbiome influences the outcome for patients undergoing stem cell transplants. The data revealed changes in the balance of bacteria affect the patient receiving a treatment for blood cancers, such as leukemia and lymphoma, making them temporarily more susceptible to infection.
Antibiotics used to prevent or treat some infections following the transplant also create an opportunity for harmful antibiotic-resistant bacteria to grow abundantly in the gastrointestinal tract. Researchers found a diversity of bacteria can substantially drop with the administration of chemotherapy and antibiotics, increasing the likelihood infections in the bloodstream.12
A second study demonstrated graft-versus-host disease is also affected by the balance of microbiota and the gut.13 The goal of a recent study published in Scientific Reports14 was to assess the efficacy of FMT to reverse antibiotic and chemotherapy-induced dysbiosis in an animal model.
Ampicillin was administered to mice causing a significant and immediate decrease in bacterial species richness and diversity, persisting for one week. However, in the mice receiving FMT, the disruption was reversed immediately.
The mice who received FMT demonstrated significant increase in bacterial species known to have anti-inflammatory properties. While chemotherapy led to a critical decrease in beneficial bacteria, FMT appeared to mitigate these effects.
Stool Donation Not as Simple as It Sounds
If you're considering donating stool, it may not be as simple as it sounds. OpenBiome is a Boston-based company aimed at expanding the safety and access to FMT. They actively recruit stool donors and pay up to $40 per donation, but carefully screen applicants.
The company claims an 85 percent success rate for treatment for C-diff using their FMT. In order to donate, individuals must be from the Boston area and pass a series of rigorous screenings.15 Applicants must be between 18 and 50 years old during their donation period, go through a clinical in-person health assessment and two rounds of blood and stool testing.
After this rigorous screening, only 3 percent of applicants are accepted. The nonprofit's clinical program director states this is because most of the chosen stool will eventually end up treating a recipient and if not carefully screened the recipient could wind up with a number of medical conditions.16
Donors who have taken antibiotics, traveled anywhere deemed risky, or if their body mass index or alcohol intake is too high, are not accepted. Once they pass the initial questionnaire, a clinician asks up to 200 more questions on other topics such as a history of depression, anxiety, allergies and asthma, some of the other common reasons a donor may be ruled out.17
Once accepted, donors can provide samples three times a week for a period of 60 days, earning approximately $40 for each donation. At the end of 60 days, if they wish to continue providing donations, they must go through the screening process again.18
Protect and Improve Your Gut Microbiome Using These Simple Steps
Hippocrates once said "all disease begins in the gut," and the more we learn, the more accurate that statement becomes. With research and study, scientists now understand your gut plays a crucial role in many health and disease processes, and actually acts as your body's second brain.
The diversity of your gut is established as an infant and affected by genetics, whether you're breast or bottle-fed and your immediate environment. As you age, it is continually affected by your food choices and medications. Diets high in sugar and processed foods reduce the variety and have a negative impact on your overall health.
Taking care of your gut not only may help prevent disease, but also may help you achieve your goals in weight loss, fitness and overall health and wellness. The consequences of a poorly developed microbiome may affect your mood, emotions, allergies and anxiety.19
Consider these strategies to improve your gut microbiome and affect recovery should you have to take antibiotics.
• Eat more fermented foods — This is one of the easiest, most effective and least expensive ways to make a significant impact on your gut microbiome. Fermentation, especially when using a starter culture, ensures you end up with a high-quality product with high levels of healthy bacteria and beneficial enzymes, including short-chain fatty acids that support healthy immune function.
• Take probiotics and prebiotics — Probiotics increase the diversity of your microbiome, while prebiotics feed beneficial bacteria, helping them to grow and thrive. Beneficial bacteria require high levels of fiber found in a variety of fruits and vegetables.20
If you starve your gut microbiome of fiber, some die off and others switch their source of nutrients to the mucus lining your gut.21 High-fiber diets help reduce your risk of premature death from all causes,22 but in order to work the fiber must be unprocessed.23 Processed supplement fiber such as inulin powder does not provide your gut bacteria what they need.
It's far better to use a supplement processed from Jerusalem artichokes where inulin is extracted. Organic whole husk psyllium is another great source, as are sunflower sprouts and fermented vegetables, the latter of which also supply beneficial bacteria.
• Avoid antibiotics — Before antibiotics, the average life expectancy was 47 years and most died from communicable diseases. Today the leading causes of death are noncommunicable, but antibiotics are triggering other health conditions. Although useful in severe infections, they also damage bacterial colonies in your gut, which may increase your risk for a number of different ailments and diseases.
If it is essential to take antibiotics, sporebiotics may be able to re-establish your gut microbiome more effectively than regular probiotics when taken in conjunction with antibiotics, as they do not contain any live strains, only spores.
• Avoid processed foods — Processed foods are high in sugar and grains and low in fiber. I believe you need 50 grams of fiber for every 1,000 calories consumed each day, as fiber feeds your good bacteria and strengthens your gut health.
Sugar is the preferred fuel for harmful bacteria, so it's important to reduce your net carbohydrate intake and eliminate processed foods and white sugar.
• Optimize your vitamin D — Optimizing your vitamin D level to 60 to 80 ng/mL is another simple yet effective means of improving your gut microbiome and reducing metabolic syndrome. Vitamin D deficiency is associated with the development of certain cancers, infections, cardiovascular disease and dysbiosis.24 In one study, researchers discovered metabolic syndrome in mice improved when supplemented with vitamin D.25
An insufficient amount of vitamin D aggravated the imbalance in the gut microbiota. This finding confirms vitamin D deficiency hinders the production of antimicrobial molecules your body uses to maintain the integrity of gut bacteria.26
from http://articles.mercola.com/sites/articles/archive/2019/02/04/fecal-microbiota-transplantation.aspx
source http://niapurenaturecom.weebly.com/blog/super-poopers-premium-donors-sought-for-fecal-transplants
0 notes
whatshouldinamethisblog · 7 years ago
Text
STOP
NEURO:
TCAs (Brain, Eyes, Heart, Colon, Prostate):
- with dementia.
- with glaucoma.
- with cardiac conductive abnormalities (pro-arrhythmic effects).
- with constipation or medication likely to cause constipation.
- with prostatism or prior history or urinary retention.
BDZs (withdraw slowly if taken for longer than 4 weeks):
- with acute respiratory failure (PO2 or PCO2).
- if fallen in past 3 months.
- for longer than 4 weeks.
Antipsychotics (Anticholinergic, Extrapyramidal Symptoms):
- long term > 1 month as hypnotics.
- long term > 1 month in Parkinson’s or Lewy Body Disease (likely to worsen extrapyramidal symptoms).
- with moderate-severe antimuscarinic/anticholinergic effects
- with a history of prostatism or previous urinary retention.
- as hypnotics unless sleep disorder if due to psychosis or dementia.
- in patients with behavioural or psychological symptoms of dementia unless symptoms are severe and other non pharmacological treatments have failed.
Levodopa or Dopaminergic Agonists:
- for benign essential tremor.
Phenothiazines (antimuscarinic):
- in patients with epilepsy (may lower seizure threshold).
- as first line tretament for anything except in palliative care where prochloprerazine for N/V/Vertigo, Chlorpromazine for hiccoughs, and Levomepromazine for N/V.
Anticholinergics:
- to treat extra-pyramidal side effects of antipsychotics medications.
- in patients with delirium or dementia.
- including first generation antihistamines.
Cholinesterase Inhibitors (Heart Block):
- with known history of bradycardia, heart block or recurrent unexplained syncope or concurrent treatment with drugs that reduce heart rate such as B-Blockers, Ca++ Blockers, and Digoxin.
SSRIs (Hyponatremia, GI Bleeding):
- with history of clinically significant hyponatremia (<130).
Citalopram and Escitalopram:
- with QT prolongation.
- or with drugs that prolong QT.
Opiates:
- for first line therapy of mild to moderate pain.
- slow release in severe pain without short acting breakthru.
- regular more than two weeks in chronic constipation without laxatives.
- long term in those with recurrent falls.
- long term in those with dementia unless for palliative care or chronic pain.
ENDO: ***Sulfonylureas of long duration of action (Hypoglycemia).
***Metformin if eGFR < 30 (Renal Failure).
Pioglitazone in patients with heart failure.
Estrogens (Breast Cancer, Uterine Cancer, DVT):
- history of breast cancer.
- history of DVT or PE.
- without progesterone in patients with intact uterus.
Any Hormone Replacement Therapy (Liver Disease, Estrogen Dependent CA, Vaginal Bleeding, Acute DVT):
- acute liver disease.
- estrogen dependent cancer.
- undiagnosed vaginal bleeding or untreated endometrial hyperplasia.
- active DVT or thrombophilic disorder.
- active or recent arterial thromboembolic disease (eg: angina or MI).
Androgens:
- in absense of primary or secondary hypogonadism.
Bisphosphonates:
- if greater than 3-5 years duration for drug holiday.
- if unexplained thigh hip or groin pain.
- given orally in patients with current or recent history of GI disease (dysphagia, esophagitis, gastritis, duodenitis, PUD, UGI Bleeding).
- if low risk of fracture (FRAX tool).
Denosumab:
- if low risk of fracture.
- if unable to have regular dental checkups.
CARDIO:
Digoxin:
- for heart failure with normal systoic ventricular function.
- for left systolic ventricular function where key interventions have not been tried.
- at long term dose greater than 125 mc/day if eGFR < 30 (risk of toxicity if digoxin plasma levels not measured as eGFR may not be an accurate indicator of clearance).
Thiazide Diuretic (Hypokalemia, Hyponatremia, Hypercalcemia, Gout):
- with current significant hypokalemia, hyponatremia, hypercalcemia or with recent or concurrent gout.
Loop Diuretic:
- as treatment for Hypertension.
- for dependent ankle edema without clinical, biochemical or radiological evidence of heart failure, liver failure, nephrotic syndrome or renal failure (leg elevation or compression hosery usually more appropriate).
Aldosterone Antagonists:
- spironolactone, eplerenone and ARBs, particularly if co-prescribed with potassium conserving drugs like ACE, amilioride or triamterene... without monitoring of serum potassium.
Verpamil or Diltiazem:
- with heart failure.
Nicorandil:
- if ulceration of the GI Tract, skin or mucosa including eyes.
- ulcers caused by Nicorandil do not respond to conventional Rx.
ACE or ARB:
- in patients with hyperkalemia.
- in combination with each other.
Centrally Acting Antihypertensives:
- methyldopa, clonidine, monoxidine.
- unless clear intolerance or or lack of efficacy with other classes of antihypertensives.
Amiodarone:
- as first line antiarrthythmic therapy in SVT.
Non-Selective B-Blockers:
- with recent history of bradycardia, heart block or uncontrolled heart failure, or asthma requiring treatment.
ANTICOAGULANTS AND ANTIPLATELETS:
Any:
- with concurrent significant bleeding risk, ie: uncontrolled severe hypertension, bleeding diathesis, recent non-trivial spontaneous bleeding.
ASA:
- long term ASA > 150 mg/day.
- with recent past history of PUD without PPI.
- in combination with Warfarin or NAOCs in patients with chronic A-Fib.
- as monotherapy for stroke prevention in A-Fib.
ASA + Clopidogrel:
- as secondary stroke prevention unless the patient has a coronary stent inserted in the previous 12 months or concurrent acute ACS or has a high grade symptomatic carotid artery stenosis (no added benefit over clopidogrel monotherapy).
Antiplatelet Agents with Warfarin or NAOCs:
- in patients with stable coronoary, cerebrovascular or perpheral artery disease (no added benefit drom dual therapy).
Warfarin or NOACs:
- for first DVT > 6 months without continuing provoking risk factors (eg:thrombophilia).
- for first PE > 6 months without continuing provoking risk factors (eg:thrombophilia).
Direct Thrombin Inhibitors (eg: Dabigatran):
- if eGFR < 30.
Factor Xa Inhibitors (eg: Rivaroxaban, Apixaban):
- if egFR < 15.
RESP:
Antimuscarinic Bronchodilators (Ipratropium, Tiotropium):
- with history of narrow angle glaucoma.
- with history of bladder outflow obstruction.
Theophylline:
- as monotherapy for Asthma or COPD.
Systemic Corticosteroids (Bleeding, Hypertension, Hyperglycemia, Hypercholesterolemia):
- instead of inhaled corticosteroids for maintenance therapy in moderate-severe COPD.
GI:
Metacloprmide and Perchlorperazine (Parkinson’s):
- with Parkinsons’s.
- after maximum treatment 5 days (metaclopromide).
***Domperidone (Heart Problems):
- for treatment other than N/V.
- after maximum treatment time of one week.
- in patients with serious underlying heart conditions.
- if receiving other medications known to prolong QT or with potent CYP3A4 inhibitors.
***PPI (Pneumonia, C-Diff, Osteoporosis):
- for uncomplicated PUD at full theraputic dose after 1-2 months (if healed, offer low dose maintenance treatment possibly on an as required basis - review anually).
Drugs likely to cause Constipation:
- anticholinergic drugs, oral iron, opioids, verapamil, aluminum antacids in patients with chronic constipation where non-constipating alternatives are available.
- for diarrhea of unknown cause, consider possibility of Clostridium Difficile infection (CDI) if there is a history of antibiotic use in the last 8 weeks or recent hospital discharge. If CDI suspected stop 1. Antimotility Drugs, 2. unnecessary antibiotics, and 3. unnecessary PPI use.
Antimotility Drugs:
- should be avoided if there is blood and mucus in stools or high fever during severe infective gastroenteritis.
Simple Antacids:
- Long term frequent dose continuous prescribing of simple antacids that relieve symptoms rather than preventing them.
Known Precipitants:
- that are associated with dyspepsia or reflux, including smoking, alcohol, coffee, chocolate and fatty foods.
GU (Orthostatic Hypotension, Dementia, Glaucoma, Prostatism):
A1-Receptor Blockers:
- in those with symptomatic orthostatic hypotension.
- in micturition syncope.
Anticholinergic Drugs:
- in dementia.
- in narrow angle glaucoma.
- chronic prostatism.
Phosphodiesterase Type 5 Inhibitors:
- in severe heart failure with hypotension.
- concurrent nitrate therapy for angina.
Diuretics:
- or other drugs that increase urinary flow with urinary incontinence.
MSK:
***NSAIDs (Bleeding, Hypertension, CHF):
- long term > 3 months for symptom relief of MSK pain where simple analgesia or topical NSAID has not been tried.
- with history of PUD or GI Bleeding unless concurrent appropriate gastroprotection.
- with concurrent oral corticosteroids or antiplatelet or antidepressant (SSRI, Venlafaxine) without concurrent appropriate GI protection.
- with severe or uncontrolled Hypertersion.
- with moderate severe Heart Failure.
- if eGFR < 50.
- with Warfarin or NAOCs.
Long Term NSAID or Colchicine:
- > 3 months for chonic treatment of gout where there is no contraindication to Allopurinol.
Diclofenac, COX-2, Ibuprofen:
- with heart failure.
- with concurrent CAD, CVD.
***Long Term Corticosteroids:
- > 3 months as monotherapy for RA.
Corticosteroids:
- other than injections, for OA.
Colchcine:
- if eGFR < 10.
Quinine:
- trial break q 3 months.
- if no benefit in leg symptoms after four weeks.
https://www.herefordshireccg.nhs.uk/library/medicines-optimisation/prescribing-guidelines/deprescribing/748-stopp-start-herefordshire-october-2016/file
0 notes
coolvoidunknown-blog · 7 years ago
Text
Clostridium difficile Infections Disease Pipeline Drugs Assessment: Clinical Trails Analysis, Player Profiles, Collaborations, Key Targets, Geographic Focus, and Data Publications, 2018
Clostridium difficile Infections Disease Pipeline Drugs Assessment: Clinical Trails Analysis, Player Profiles, Collaborations, Key Targets, Geographic Focus, and Data Publications, 2018
 Overview:
Clostridium difficile is a bacterium which infects the bowel and caused diarrhea. This infection is most commonly seen in people who were recently been treated with antibiotics and it can be spread easily to others. Clostridium difficile is also called as C. difficile or C.diff. C.diff infections may cause serious bowel problems. Symptoms of C.diff infections includes watery diarrhea, painful cramps in tummy, dehydration, dry mouth, head ache, loss of weight and appetite etc.
C.diff can be diagnosed by enzyme immunoassay, polymerase chain reaction, GDH or EIA. Treatment for Clostridium difficile infection includes antibiotics course.
 A sample of this report is available upon request @
https://www.precisionbusinessinsights.com/market-reports/clostridium-difficile-infectionsdisease-pipeline-drugs-assessment/#ulp-4H8Z4LpNMLEuOnnx
 Segmentation:
By Trial Phase, Clostridium difficile Infections pipeline drugs are segmented as:
·         Preclinical Trials
·         Phase 1
·         Phase 2
·         Phase 3
·         Phase 4
By Company, Clostridium difficile Infections pipeline drugs are segmented as:
·         Synthetic Biologics
·         Da Volterra
·         Pfizer Inc.
·         Valneva SE
·         Seres Therapeutics
·         Summit Therapeutics
·         Rebiotix Inc.
·         CRESTOVO
·         Merck
·         XBiotech
·         Others
By Drugs, Clostridium difficile Infections pipeline drugs are segmented as:
·         Vancomycin
·         Fidaxomicin
·         Metronidazole
·         Ridinilazole
·         Cadazolid
·         Bezlotoxumab
·         Others
 By Type of Condition Clostridium difficile Infections pipeline drugs are segmented as:
·         Systemic JIA
·         Oligoarthritis
·         Polyarticular arthritis,rheumatoid factor negative/ rheumatoid factor positive
·         Psoriatic arthritis
·         Enthesitis-related arthritis
·         Undifferentiated arthritis
By Route of Administration, Clostridium difficile Infections pipeline drugs are segmented as:
·         Oral
·         Parenteral
 To view TOC of this report is available upon request @
https://www.precisionbusinessinsights.com/market-reports/clostridium-difficile-infectionsdisease-pipeline-drugs-assessment/#ulp-c654SbFYO64MsOhu
  Space Analysis:
·         In July 2016, Valneva SE completed Phase II study for its prophylactic vaccine candidate VLA84 targeting primary prevention of difficile infection (CDI). The study met its primary endpoint in terms of identifying the dose/formulation with the highest seroconversion rate against both toxins A and B and confirmed the favorable safety profile observed in Phase
·         In June 2017, Seres Therapeutics, Inc. initiated Phase 3 clinical study of its SER-109 (ECOSPOR III) in patients with multiply recurrent difficile infection and also commenced Phase 1b clinical trial evaluating SER-262 in patients with primary Clostridium difficile infection (CDI).
·         On May 11, 2017 The U.S. Food and Drug Administration (FDA) granted a Breakthrough Therapy Designation for SYN-004 (ribaxamase) of Synthetic Biologicsfor the prevention of Clostridium difficile infection.
·         In October 2015, RBX2660 of Rebiotix was grated orphan drug status and fast track designation from U.S.FDA for its potential to prevent recurrent C. diff. infection.
 Report Description:
Clostridium difficile InfectionsDisease Pipeline Drugs Assessment report studies the various therapeutics under clinical development for Clostridium difficile Infections treatment along with targets for various drug candidate. The report provides plethora of information pertaining to trail phases, companies involved in the Clostridium difficile Infections disease pipeline drugs development. This report studies the dynamics of the Clostridium difficile Infections Disease Pipeline Drugs i.e. drivers, challenges and opportunities which are significantly impacting the product development. The report provides various information pertaining the clinical trials such as designation, grants, patents, and technology among others. Moreover, the report on Clostridium difficile Infections disease pipeline drugs assessment comprehensively presents the geographic location, trial status information along with key players involved in the therapeutics development.
 Need more information about this report @
https://www.precisionbusinessinsights.com/market-reports/clostridium-difficile-infectionsdisease-pipeline-drugs-assessment/#ulp-14mlyhjMGhVjZqa3
 Key Features of the Report:
·         Provides the information related to universities and research institutes working in the therapeutics development
·         Report comprehensively covers the all active and discontinued studies
·         Studies the entire pipeline with special emphasis on companies actively involved in the therapeutics development
·         Presents the prominent targets for drug development in each stage of clinical trial
·         Provides the in-depth analysis on the each drug candidates in the clinical trial phases
 Get access to full summary @
https://www.precisionbusinessinsights.com/market-reports/clostridium-difficile-infectionsdisease-pipeline-drugs-assessment/
About Precision Business Insights
 Precision Business Insights is one of the leading market research and business consulting firm, which follow a holistic approach to solve needs of the clients. We adopt and implement proven research methodologies to achieve better results. We help our clients by providing actionable insights and strategies to make better decisions. We provide consulting, syndicated and customised market research services based on our client needs.
 Contact to Precision Business Insights,
 Kemp House,
152 – 160 City Road,
London EC1V 2NX
 Toll Free (US): +1-866-598-1553
Website @ https://www.precisionbusinessinsights.com
0 notes
sherristockman · 8 years ago
Link
Poop Pills Can Combat Deadly Infections Dr. Mercola By Dr. Mercola While it would seem that a fecal transplant in capsule form would be a somewhat bitter pill to swallow, scientists conducting a randomized clinical trial1 found this mode of transportation, in a matter of speaking, for fecal therapy was easier and just as effective for treating patients infected with the serious and dreaded Clostridium difficile infection (RCDI), or simply “C. diff.,” as receiving a fecal transplant via enema or colonoscopy, also known as fecal microbiota transplantation (FMT). Further, FMT in pill form has the capacity to improve patients’ quality of life, as it caused fewer adverse events.2 For those who may be unaware of this protocol, fecal transplants are now not just common, but according to one study, so successful that the first trial was stopped early because the researchers deemed it unethical to withhold the treatment from patients (as some typically are given alternative therapies). As noted by NPR: “That's because C. diff. is kind of a special case. It's a very invasive microbe that has repeatedly been assaulted by antibiotics which have caused a collapse in other microbes. So it's an easy environment for microbes in a donor stool to invade.”3 C. Diff.: Common Bacterium in Hospital Environments One of the problems with C. difficile is that it’s one of the most common health care-associated infections and one of the foremost reasons hospital patients develop debilitating, recurrent diarrhea that’s hard to get a handle on, medically. It’s especially rampant among older individuals on antibiotics for other conditions. CIDRAP states: “(C. diff.) can also be difficult to completely cure. As a result, recurrent infections have become a growing challenge. At least 20 percent of patients who get an initial CDI have a recurrent infection within eight weeks, with the risk of RCDI being as high as 50 percent to 60 percent after three or more infections.”4 Researchers at Brown University, where one program focuses on digestive microbes such as bacteria, fungi and viruses (human microbiomes), say C. diff. became hard to manage when antibiotics prescribed for other conditions disturbed what may have been perfectly functioning, benign gut organisms. By no means a trifling infection, Newsweek pulls no punches as it calls C. diff. both “nasty” and “deadly.” Antibiotics may be the usual treatment in hospitals, but they only contribute to the problem by effectively wiping out beneficial bacteria in patients’ collective microbiome that might keep C. diff. in check, CIDRAP observes. In essence, FMT can be explained as feces being transferred from one healthy donor to the gastrointestinal tract of a C. diff. infected patient. The purpose is to “reintroduce healthy bacteria into the gut (as) a non-antibiotic therapy that's shown promise in clinical studies.”5 What Happens When Your Gut Biome Becomes This Compromised? C. diff. infection impacts half a million people in the U.S. every year. Further, it’s fatal for 15,000 of them, also every year, according to the Centers for Disease Control and Prevention (CDC).6 Still, there have been patients who found the prospect of fecal transplant therapy, even through surgical means, to be just too daunting. In fact, efforts have actually been made to extract the beneficial bacteria from the fecal matter to make the idea of swallowing it more palatable, but the effort failed. Far from being a brand-new, innovative idea, using poop to fight the effects of C. diff. and other problems in patients has been around since at least the late 1950s. Different names, besides FMT, have included fecal biotherapy and fecal flora reconstitution. One study explains the science behind it: “FMT involves reconstituting the normal intestinal microflora in a diseased person by infusion (via nasogastric tube, enema or colonoscopy) of a liquid suspension of stool from a healthy donor. The first report of the use of FMT (for a patient with non-CDI pseudomembranous colitis) was published in 1958. Since then, there has been mounting evidence supporting its use in recurrent CDI.”7 Your Microbiome Can Make or Break Your Health How your microbiome works is still being scrutinized by scientists, especially in the way it can make or break your overall health. It’s clear that certain foods are considered positive for “feeding” your microbiome. Foods containing fiber are at the top of the list as they release nutrients for your gut lining. The connection between what you eat and how healthy your gut is are closely interconnected, so consider adding more fiber, especially if you aren’t getting the 50 grams of fiber per 1,000 calories you eat that I recommend. One way fiber benefits your health is by providing beneficial bacteria in your gut with the materials needed to thrive. These beneficial bacteria assist with digestion and absorption of your food, and play a significant role in your immune function. One of the best ways to regain optimal balance in your gut is by eating fermented foods. Besides kimchi and other fermented vegetables, which you can make at home very easily, there are also fermented beverages such as kefir and yogurt, all providing trillions of beneficial bacteria — far more than you can get from a probiotics supplement. Poop Pills, a Colonoscopy or the Other Alternatives? It’s been a tough call for scientists and physicians alike, trying to determine which is worse: C. diff., antibiotics, colonoscopies (the most successful in terms of introducing fecal matter into patients) or the new poop pill-popping protocol. C. diff. being what it is comes with serious, life-altering symptoms, which Medline Plus8 says can include: Watery diarrhea multiple times daily Stomach cramps Fever Dehydration Nausea Abdominal pain and tenderness A colonoscopy is an example of an invasive procedure, but there’s also the fact that patients typically undergo mild sedation, which introduces another risk because their breathing may become too slow. Further, there’s the chance that in the course of the procedure, the patient’s intestinal wall could be punctured, which could introduce life-threatening infections. Time observed: “The benefits of swallowing a capsule are also undeniable compared to swallowing — or trying to swallow — a feeding tube through which a slurry of fecal matter is flowing through. (That’s the way that doctors testing fecal transplants originally administered their doses.) That carries the risk of aspirating some of the fecal slurry into the lungs — not to mention the unpleasantness of introducing feces to the mouth area and accidentally breathing it in.”9 The Poop-in-a-Capsule Trial Dina Kao, a gastroenterologist at the University of Alberta in Canada, used the pills described by Time10 as “fecal matter manufactured into a capsule” for 116 patients in the trial. Compared to a colonoscopy, both methods showed a 90 percent reduction in C. diff. relapses. All 116 study subjects had suffered a minimum of three bouts of C. diff. and were randomly assigned a poop swap via either the capsule or colonoscopy. It must have been an exercise in “mind over matter” for the patients who were required to swallow down 40 capsules in one sitting, which took an average of a half-hour to an hour. The reduction in C. diff. relapse was determined after 90 percent of the patients remained C. diff.-free after 12 weeks. Preeti Malani, professor of medicine at the University of Michigan, who wrote an editorial to go with the study, noted: “Based on this study, I think it would be very reasonable to think about fecal transplant capsules as your preferred approach. If it were myself or a family member, I think avoiding colonoscopy would be helpful.” Still, Melani and other researchers believe more studies are needed, not only to confirm the results found in Kao’s study, but also to get a better understanding of how fecal transplant works. Kao herself says she plans to study all the components of fecal transplants to get a clearer picture of what exactly helps control C. diff. Besides C. diff., microbe transplanting via a capsule is also a therapy currently used for obesity, diabetes, colitis and Crohn’s disease. It’s a way gut bacteria can be positively linked to lowering the risks of such disorders and conditions as obesity, allergies, asthma and even some mental illnesses. A Protocol Still Unapproved by Government Agencies While fecal transplantation may at first glance come across as quackery of the highest degree, once you understand the process, it’s clear it’s a successful way to swap bad bacteria for good. Kao, whose first reaction upon the successful trial, quipped, “It’s absolutely insane. We just don’t see (this) kind of efficacy with drugs,”11 added that she believes the favorable outcome of the fecal transplant pills will “transform” the way conventional medicine at large thinks about the unconventional therapy. She listed several of the benefits over the current protocols of antibiotics or surgery. Poop pills are: Noninvasive Less expensive Free of the risks associated with sedation Can be done in a doctor’s office As it stands, the Food and Drug Administration (FDA) hasn’t yet given the proverbial green light to fecal transplants. It does, however, permit doctors to perform the therapy for patients not currently responding favorably to other forms of remediation, but only as long as patients understand that the poop pill is still being scrutinized as a viable treatment. In addition, CIDRAP notes that in March 2016, the FDA proposed regulations that would further restrict use of FMT by requiring that either the patient recipient or the treating clinician personally know the donor — a restriction that, as yet, is not finalized. Interestingly, among patients who’ve been asked what they thought of the idea of swallowing poop pills, most responded that after all was said and done, it wasn’t too bad. Newsweek observes that two-thirds of the 57 patients who got the pills described the experience as “not at all unpleasant,” while 44 percent of the 59 patients who underwent FMT via a colonoscopy were not as positive. Perhaps when the patients remembered the alternative — that to them, poop pills were a hero of sorts due to their ability to stop the unstoppable on the other end — the therapy could only be seen in a positive light. As Kao concluded, “We still don’t understand what’s going on, and in these other conditions it’s not as clear-cut that the disturbance in the bacterial composition is the cause. Stool is such a complex mixture.”12
0 notes
cdifffoundation · 8 years ago
Text
Inquire and Consider Becoming A Candidate In a C. difficile Infection Clinical Trial To Help You - Help Them - Help Others
Inquire and Consider Becoming A Candidate In a C. difficile Infection Clinical Trial To Help You – Help Them – Help Others
Every scientific research and development, every clinical trial in progress is a glimmer of hope………..HOPE for clinically safe and approved avenues to prevent and treat a C. difficile infection.
    Listed below you will find a web link that will redirect you to obtain information that pertains to organizations who have on-going C. difficile Prevention and Treatment clinical trials in progress.  
C…
View On WordPress
0 notes
cdifffoundation · 6 years ago
Text
Contagion®Interview with Ken Blount, PhD Chief Scientific Officer at Rebiotix, a Ferring Company, and Discussed the Phase II Microbiota Based RBX2660 Clinical Trial Results and Plans for Next Steps
Contagion®Interview with Ken Blount, PhD Chief Scientific Officer at Rebiotix, a Ferring Company, and Discussed the Phase II Microbiota Based RBX2660 Clinical Trial Results and Plans for Next Steps
OCT 03, 2019 | ALEXANDRA WARD
Contagion Live
To read the interview in its entirety – click on the following link to be redirected:
https://www.contagionlive.com/news/phase-2-results-microbiotabased-rbx2660-safe-efficacious-for-preventing-c-diff-recurrence
Investigators at IDWeek 2019 presented the final, 24-month analysis of data…
View On WordPress
0 notes
cdifffoundation · 7 years ago
Text
Learn More About Clostridium difficile (C.diff., C.difficile) infection and Recurrent CDI Clinical Trials In Progress
      The C Diff Foundation has implemented a global campaign to raise awareness of Clostridium difficile infection (C.difficile) clinical trials, clinical studies, clinical research and observational studies evaluating interventions for C. difficile prevention, treatments, and environmental safety.
In the USA: Nearly half a million Americans suffer from Clostridium difficile (C. diff.)…
View On WordPress
0 notes