#Recurrent C. diff. Infections rCDI Clinical Trials

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Microbiota Restoration Therapy (MRT) (Drug Platform) Reduces Antibiotic-resistant Bacteria Gut Colonization In Patients with Recurrent C. difficile Infection (rCDI)

Microbiota Restoration Therapy (MRT) (Drug Platform) Reduces Antibiotic-resistant Bacteria Gut Colonization In Patients with Recurrent C. difficile Infection (rCDI)

Microbiota restoration reduces antibiotic-resistant bacteria gut colonization in patients with recurrent Clostridioides difficile infection from the open-label PUNCH CD study Amy Langdon, Drew J. Schwartz, Christopher Bulow, Xiaoqing Sun, Tiffany Hink, Kimberly A. Reske, Courtney Jones, Carey-Ann D. Burnham, Erik R. Dubberke & Gautam Dantas for the CDC Prevention Epicenter…

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New donor screening protocols for clinical trials involving fecal microbiota transplantation https://ift.tt/2HMnWDN

Back in May, I wrote a blog post about fecal microbiota transplantation (FMT), or stool transplantation. FMT is considered standard-of-care therapy to treat recurrent Clostridium difficile (C. diff) infections. In this procedure, stool from a healthy donor is placed into the gut of a patient, usually via colonoscopy, to restore helpful bacteria that help protect against recurrent C. diff infection (rCDI).

An important event occurred after my initial post. On June 13, 2019, the FDA issued a safety alert concerning the risk of transmission of multi-drug resistant organisms (MDRO) through FMT. MDROs are bacteria that are resistant to one or more antibiotics.

Safety alert leaves many questions unanswered

The safety alert was issued in response to the transmission of a specific MDRO from donor stool into two patients following FMT. Tragically, one of these individuals died. The FDA announcement provides very few details regarding these cases, and it does not provide information on the cause of this patient’s death. What is known is that these two patients were given FMT as part of a research protocol and not as part of clinical care to treat rCDI.

As I mentioned in my previous post, FMT is supported by guidelines, but is still considered investigational and is not currently FDA-approved. FMT can be performed for clinical care to treat rCDI. But an FMT for any other indication can only be performed in the setting of a clinical trial.

The FDA has not yet disclosed the indication or reason for the FMT for the two patients mentioned in their safety alert, but the FDA did note that the patients were immunocompromised. FMT has been shown to be safe in immunocompromised patients, but generally these patients are at increased risk for infections. Additionally, it was noted that the donor material used in this research protocol had not been screened for MDROs.

FDA institutes new screening requirement for donor stool

Following this event, the FDA now requires MDRO screening for donor stool for all active and future FMT study protocols. Worldwide, screening is being recommended for clinical protocols as well, and this is expected to be supported by an upcoming guideline.

It is important to note that all major stool banks in the US and around the world had implemented screening protocols to detect MDROs and exclude potential donors who test positive well prior to this event. This includes OpenBiome, a large, non-profit stool bank that is widely used in the US and has provided over 45,000 treatments.

Prior to this there had been no previous transmissions of MDROs reported, highlighting that this procedure still remains very safe overall. That being said, this event highlights the need for adherence to standardized screening protocols, which is key for patient safety.

The FDA has reached out to sites that have ongoing FMT protocols to ensure appropriate screening procedures are being followed. Any protocols not utilizing appropriate screening practices were put on hold. The FDA has not released any further information about how many protocols or sites were affected by this step.

Follow me on Twitter @DrJessicaA

The post New donor screening protocols for clinical trials involving fecal microbiota transplantation appeared first on Harvard Health Blog.

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New donor screening protocols for clinical trials involving fecal microbiota transplantation

Back in May, I wrote a blog post about fecal microbiota transplantation (FMT), or stool transplantation. FMT is considered standard-of-care therapy to treat recurrent Clostridium difficile (C. diff) infections. In this procedure, stool from a healthy donor is placed into the gut of a patient, usually via colonoscopy, to restore helpful bacteria that help protect against recurrent C. diff infection (rCDI).

An important event occurred after my initial post. On June 13, 2019, the FDA issued a safety alert concerning the risk of transmission of multi-drug resistant organisms (MDRO) through FMT. MDROs are bacteria that are resistant to one or more antibiotics.

Safety alert leaves many questions unanswered

The safety alert was issued in response to the transmission of a specific MDRO from donor stool into two patients following FMT. Tragically, one of these individuals died. The FDA announcement provides very few details regarding these cases, and it does not provide information on the cause of this patient’s death. What is known is that these two patients were given FMT as part of a research protocol and not as part of clinical care to treat rCDI.

As I mentioned in my previous post, FMT is supported by guidelines, but is still considered investigational and is not currently FDA-approved. FMT can be performed for clinical care to treat rCDI. But an FMT for any other indication can only be performed in the setting of a clinical trial.

The FDA has not yet disclosed the indication or reason for the FMT for the two patients mentioned in their safety alert, but the FDA did note that the patients were immunocompromised. FMT has been shown to be safe in immunocompromised patients, but generally these patients are at increased risk for infections. Additionally, it was noted that the donor material used in this research protocol had not been screened for MDROs.

FDA institutes new screening requirement for donor stool

Following this event, the FDA now requires MDRO screening for donor stool for all active and future FMT study protocols. Worldwide, screening is being recommended for clinical protocols as well, and this is expected to be supported by an upcoming guideline.

It is important to note that all major stool banks in the US and around the world had implemented screening protocols to detect MDROs and exclude potential donors who test positive well prior to this event. This includes OpenBiome, a large, non-profit stool bank that is widely used in the US and has provided over 45,000 treatments.

Prior to this there had been no previous transmissions of MDROs reported, highlighting that this procedure still remains very safe overall. That being said, this event highlights the need for adherence to standardized screening protocols, which is key for patient safety.

The FDA has reached out to sites that have ongoing FMT protocols to ensure appropriate screening procedures are being followed. Any protocols not utilizing appropriate screening practices were put on hold. The FDA has not released any further information about how many protocols or sites were affected by this step.

Follow me on Twitter @DrJessicaA

The post New donor screening protocols for clinical trials involving fecal microbiota transplantation appeared first on Harvard Health Blog.

New donor screening protocols for clinical trials involving fecal microbiota transplantation published first on https://drugaddictionsrehab.tumblr.com/

[mhealthb007]

Back in May, I wrote a blog post about fecal microbiota transplantation (FMT), or stool transplantation. FMT is considered standard-of-care therapy to treat recurrent Clostridium difficile (C. diff) infections. In this procedure, stool from a healthy donor is placed into the gut of a patient, usually via colonoscopy, to restore helpful bacteria that help protect against recurrent C. diff infection (rCDI).

An important event occurred after my initial post. On June 13, 2019, the FDA issued a safety alert concerning the risk of transmission of multi-drug resistant organisms (MDRO) through FMT. MDROs are bacteria that are resistant to one or more antibiotics.

Safety alert leaves many questions unanswered

The safety alert was issued in response to the transmission of a specific MDRO from donor stool into two patients following FMT. Tragically, one of these individuals died. The FDA announcement provides very few details regarding these cases, and it does not provide information on the cause of this patient’s death. What is known is that these two patients were given FMT as part of a research protocol and not as part of clinical care to treat rCDI.

As I mentioned in my previous post, FMT is supported by guidelines, but is still considered investigational and is not currently FDA-approved. FMT can be performed for clinical care to treat rCDI. But an FMT for any other indication can only be performed in the setting of a clinical trial.

The FDA has not yet disclosed the indication or reason for the FMT for the two patients mentioned in their safety alert, but the FDA did note that the patients were immunocompromised. FMT has been shown to be safe in immunocompromised patients, but generally these patients are at increased risk for infections. Additionally, it was noted that the donor material used in this research protocol had not been screened for MDROs.

FDA institutes new screening requirement for donor stool

Following this event, the FDA now requires MDRO screening for donor stool for all active and future FMT study protocols. Worldwide, screening is being recommended for clinical protocols as well, and this is expected to be supported by an upcoming guideline.

It is important to note that all major stool banks in the US and around the world had implemented screening protocols to detect MDROs and exclude potential donors who test positive well prior to this event. This includes OpenBiome, a large, non-profit stool bank that is widely used in the US and has provided over 45,000 treatments.

Prior to this there had been no previous transmissions of MDROs reported, highlighting that this procedure still remains very safe overall. That being said, this event highlights the need for adherence to standardized screening protocols, which is key for patient safety.

The FDA has reached out to sites that have ongoing FMT protocols to ensure appropriate screening procedures are being followed. Any protocols not utilizing appropriate screening practices were put on hold. The FDA has not released any further information about how many protocols or sites were affected by this step.

Follow me on Twitter @DrJessicaA

The post New donor screening protocols for clinical trials involving fecal microbiota transplantation appeared first on Harvard Health Blog.

from Harvard Health Blog https://ift.tt/34mfC7p Original Content By : https://ift.tt/1UayBFY

[sherristockman]

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

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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…

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Rebiotix Announces Expansion of Phase 1 Study For Prevention of Recurrent C.diff. Infection Oral Capsule Microbiota Product RBX7455

Rebiotix Announces Expansion of Phase 1 Trial of the Company’s Oral Capsule Microbiota Product, RBX7455, Following Successful Completion of Initial Study Arms Additional cohorts to examine potential of reduced dosing regimens of RBX7455 for the prevention of recurrent Clostridium difficile infection Rebiotix Inc., a clinical-stage microbiome company focused on harnessing the power of the human…

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Rebiotix Features Three Posters Highlighting RBX2660 Clinical and Microbiome Data at ID Week™ 2017 in San Diego, October 4th - 8th

Rebiotix Features Three Posters Highlighting RBX2660 Clinical and Microbiome Data at ID Week™ 2017 in San Diego, October 4th – 8th

Positive Topline Data from Open-Label Phase 2 Trial of RBX2660 in Recurrent Clostridium difficile to be Presented for First Time

      Rebiotix Inc., a clinical-stage microbiome company focused on harnessing the power of the human microbiome to treat challenging diseases, today announced that three posters highlighting RBX2660 clinical and microbiome data will be featured at ID Week™ 2017 in San…

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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…