#rcdi

[postsofbabel]

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[cdifffoundation]

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…

[rootsanalysis-blog]

The human microbiome market is anticipated to grow at a CAGR of 24% till 2035

With the increasing concept of precision medicine, several scientists have demonstrated interest in the therapeutic manipulation of human microbiome (commonly gut bacteria) for the treatment of a wide range of disease indications.

  Roots Analysis has announced the addition of “The Human Microbiome Market, (4th Edition) 2022-2035” report to its list of offerings.

 The microbiome-based therapies pipeline features six drugs in phase III clinical development, over 200 candidates in other clinical and preclinical stages of development along with more than 60 diagnostics and screening / profiling tests that are commercialized for the detection of various diseases. However, the current microbiome market is driven by the fecal microbiota therapies approved by the FDA, particularly for the recurrent CDI and the commercialized diagnostic tests available to the patients. The human microbiome remained a largely unexplored area until 2007 when the Human Microbiome Project (HMP) was initiated. Given the role of microbiota in disease development and pathogenesis, the concept of microbiome-based therapeutics has generated significant enthusiasm within the medical science community, thereby, defining a new frontier in the field of medicine. 

 Key Market Insights

 Over 230 drug candidates are currently being developed by more than 70 drug developers

Nearly 30% of the pipeline drugs are in clinical phase of development, while more than 150 drugs are in preclinical and discovery stages. Clinical stage drugs are primarily being developed for infectious diseases and digestive disorders, while candidates in preclinical and discovery stages are focused on oncological disorders.

 More than 75 diagnostics and screening / profiling test are available / under development

Of these, around 80% of the tests are available in the market, while rest are under development. More than 40 companies are engaged in providing these tests; these are primarily based in North America (45%) and Europe (39%). It is worth highlighting that majority (68%) of the players are small companies.

 FMTs are the only commercially available microbiome therapies approved by the FDA

These therapies are primarily used for the treatment of recurrent Clostridium difficile infection (rCDIs). It is worth mentioning that more than 400 trials have been registered for evaluating these therapies for a wide range of indications.

 Partnership activity in this domain has increased at a CAGR of 26%, between 2017 and 2021

Maximum number of partnerships were established in 2021, indicating a recent rise in the interest of players engaged in this domain. It is worth highlighting that majority of the deals were R&D agreements, representing over 35% of the total number of partnerships signed in the given time period.

 More than USD 1 billion has been invested by both private and public investors, since 2017

Of the total amount invested, over USD 563 million was raised through venture capital financing, representing over 56% of the overall funding activity in this domain. Further, 36 instances of grants / awards were also reported, wherein players collectively raised more than USD 137 million.

 Outsourcing has become an integral part of the microbiome and live biotherapeutics development process

Presently, over 25 service providers claim to offer a multitude of contract manufacturing services for microbiome and live biotherapeutic products. It is worth noting that close to 10 firms were established post 2010 and around 45% of the players are located in Europe.

 Microbiome therapeutics are anticipated to capture more than 60% share of total microbiome market by 2035

As late-stage therapeutics will get approved by the FDA in the foreseen future, the microbiome therapeutics market is likely to grow at an annualized rate of 37% till 2035. It is worth mentioning that microbiome diagnostics is likely to capture 20% of the total microbiome market share by 2035.

 To request a sample copy / brochure of this report, please visit

https://www.rootsanalysis.com/reports/281/request-sample.html

 Key Questions Answered

§  Who are the leading players engaged in the development of microbiome therapeutics?

§  Which are the key microbiome based drugs being developed across various stages of development?

§  Which companies are actively involved in conducting clinical trials for microbiome therapeutics and FMTs?

§  Who are the leading players engaged in the development of microbiome diagnostics and screening / profiling tests?

§  Which types of partnership models are commonly adopted by industry stakeholders?

§  Who are the key investors in the field of human microbiome therapeutics and diagnostics?

§  What are the different initiatives undertaken by big pharma players for the development of human microbiome therapeutics in the recent past?

§  What is the role of various start-ups engaged in developing human microbiome therapeutics?

§  Which are the most commonly targeted therapeutic indications for which microbiome therapeutics are being developed?

§  What are the various steps involved in the manufacturing of microbiome therapeutics?

§  What are the key considerations for selecting a CMO / CRO for manufacturing of microbiome therapeutics?

§  What are the various algorithms / tools used to analyze data generated from microbiome research?

§  How is the current and future opportunity, related to microbiome therapeutics, diagnostics and FMT likely to be distributed across key market segments?

§  What are the various non-pharma applications of microbiome products?            

 The financial opportunity within the human microbiome therapeutics market has been analyzed across the following segments:

§  Type of Product

§  Probiotic Drugs

§  Other Drugs

 §  Target Indication

§  Recurrent C. difficile Infection

§  Necrotizing Enterocolitis

§  Primary Hyperoxaluria

§  Graft versus Host Disease

 §  Therapeutic Area

§  Infectious Diseases

§  Digestive and GI Disorders

§  Rare Disorders

 §  Route of Administration

§  Oral Route

§  Rectal Route

 §  Type of Formulation

§  Capsules

§  Suspensions

§  Enemas

 §  Key Geographical Regions

§  North America

§  Europe

§  Asia Pacific

  The financial opportunity within the human microbiome diagnostics and screening / profiling tests market has been analyzed across the following segments:

§  Target Indication

§  Irritable Bowel Syndrome

§  Inflammatory Bowel Disease

§  Colorectal Cancer

§  Diabetes Mellitus

 §  Key Geographical Regions

§  North America

§  Europe

§  Asia Pacific

 The financial opportunity within the fecal microbiota therapies market has been analyzed across the following segments:

§  Key Geographical Regions

§  North America

§  Europe

§  Asia Pacific

 The report features inputs from eminent industry stakeholder(s), who were very optimistic concerning the growth of the human microbiome market. It includes detailed transcripts of the discussions held with the senior representatives of the stakeholder firms, including:

§  Charlie Badham (Senior Manager, Corporate Development, 4D Pharma)

§  Nicholas Monsul (Co-founder and Chairman, Quorum Innovations)

§  Alicia Scheffer (Chief Executive Officer, Floragraph)

§  Aaron Wright (Senior Scientist, Pacific Northwest National Laboratories)

§  Alexander Lin (Associate General Manager, Chung Mei Pharmaceutical)

§  Alexander Segal (Vice President, Business Development, Universal Stabilization Technologies)

§  Assaf Oron (Chief Business Officer, BiomX)

§  Debbie Pinkston (Former Vice President, Sales and Business Development, List Biological Laboratories)

§  Veronika Oudova (Co-founder and Chief Executive Officer, S-Biomedic)

§  Colleen Cutcliffe (Co-founder and Chief Executive Officer, Pendulum Therapeutics)

§  Nikole Kimes (Co-founder and Chief Executive Officer, Siolta Therapeutics)

§  James Burges (Ex-Co-founder and Vice President of Innovation, OpenBiome)

§  Gregory J Kuehn (Vice President, Business Development and Marketing, Metabiomics)

§  JP Benya (Ex-Vice President, Operations, Assembly Biosciences)

§  Lee Jones (President and Chief Executive Officer, Rebiotix)

§  Mark Heiman (Ex-Chief Scientific Officer and Vice President, Research, MicroBiome Therapeutics)

§  Pierre-Alain Bandinelli (Chief Strategy Officer, Da Volterra)

   The report also includes detailed profiles of the companies (listed below) engaged in developing microbiome therapeutics, diagnostics and screening / profiling test; each profile features an overview of the company, its financial information (if available), details on its product portfolio, recent developments, and an informed future outlook.

§  4D Pharma

§  Biosotia Microbiomics

§  DNA Genotek

§  Finch Therapeutics

§  GoodGut

§  Infant Bacterial Therapeutics

§  Invivo Healthcare

§  MaaT Pharma

§  OxThera

§  Qu Biologics

§  Rebiotix

§  Seres Therapeutics

§  Servatus

§  Shoreline Biome

 For additional details, please visit https://www.rootsanalysis.com/reports/view_document/human-microbiome-market/281.html or email sales@rootsanalysis.com

 You may also be interested in the following titles:

1.       Targeted protein degradation market, 2022-2035

2.       Cell Therapy Manufacturing Market, 2021-2030

3.       Single-Use Upstream Bioprocessing Technology / Equipment Market, 2022-2035

About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

 Contact:

Ben Johnson

+1 (415) 800 3415

+44 (122) 391 1091

Ben.johnson@rootsanalysis.com

[isrealforus]

Insights on the gut microbiome could shape more powerful, precise treatment

In a recently published study, investigators explore how the dynamics of bacterial species may influence the success of fecal microbiota transplantation in treating recurrent C. difficile infection. The team presents an algorithm to design personalized probiotic cocktails for patients with unhealthy gut microbiomes due to rCDI. from Bacteria News -- ScienceDaily https://ift.tt/2XtW9jo via mold removal Boca Raton mold removal Boca Raton from Blogger https://ift.tt/2ER94W9 August 04, 2020 at 03:56PM

[aracadia]

Rcdi

spell your username without using the letters in your name

mine is ptipi

[ebenpink]

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.

from Harvard Health Blog https://ift.tt/34mfC7p via IFTTT https://ift.tt/eA8V8J

[yuriwangfingermedia]

糞便真能救命！　3歲童腸疾靠親姊便便改善 【健康醫療網／記者林怡亭報導】一名年約3歲男童，因罹患發炎性腸道疾病，持續出現腹瀉、血便而住院，經醫師診斷出被高度抗藥性的困難梭菌感染，多次採抗生素治療無效，醫師決定採用微菌叢植入術治療，將男童親姐姐的便菌叢移植到男童腸道，成功緩解症狀，也順利改善腸道菌相的平衡。 長期使用抗生素　易致腸道菌相改變 林口長庚醫院分子感染症醫學研究中心主任、兒童感染科教授邱政洵表示，困難梭菌引起的偽膜性大腸炎及毒性巨結腸症，通常是因為大量、長期使用廣效性抗生素之後，腸道菌相改變，加上困難梭菌感染，釋放出毒素，而導致的嚴重腸道併發症。 治療困難梭菌感染　微菌叢植入術效果顯著 治療困難梭菌引起的感染，通常必須使用更多的抗生素如萬古黴素及咪唑尼達，但是治療有可能會失敗，也可能會篩選出更嚴重的抗藥性細菌感染，即使病情初步改善，此感染也常常會復發。 邱政洵說，「微菌叢植入術(FMT)」，則提供了一個合乎環保及自然的治療方式，國外已有許多臨床研究證實具有非常好的療效，且相較於傳統的抗生素治療更具成本效益。 符合特管辦法即能捐　長庚成立微菌銀行 自衛福部107年9月發布特管辦法，新增微菌叢植入術治療嚴重或反覆性困難梭菌感染(rCDI)，開放以灌腸、內視鏡或口服膠囊方式，將健康捐贈者的腸道菌叢，植入病人腸道，用來施行於反覆性或常規治療無效的困難梭菌感染病人。 邱政洵指出，目前微菌叢植入的進行，都須符合特管辦法進行嚴格的病人與捐贈者篩檢。而林口長庚醫院已成立「長庚微菌治療中心」與「微菌銀行」，至今年6月共完成5例微菌叢植入治療，其年紀遍及3歲至88歲，這些病人移植2到4週之後，幾乎恢復完全正常的腸道菌相，追蹤從2個月到1年多，目前都無復發的現象。 困難梭菌感染　���明腹瀉應提高警覺 若為長期住院有使用過廣效性抗生素的病人、罹患發炎性腸道疾病以及有慢性疾病、免疫功能較差的病人，都是困難梭菌感染的高風險族群。邱政洵提醒，若出現不明原因腹瀉，甚至合併腹脹、腹痛或血便，就要懷疑可能是困難梭菌感染，應儘快就醫診斷治療。 【延伸閱讀】愛的印記讓妳沒自信？　醫美讓妊娠紋從人生中退場 資料來源：健康醫療網 游勝鈞;游胜钧;指動傳播科技;指动传播科技;指傳媒;指传媒;華民通訊社;华民通讯社;民生新聞網;民生新闻网,健康醫療網,資料來源：健康醫療網新聞

[cdifffoundation]

  Please -- Do Not Take Medicine Into Your Own Hands, You Are NOT Out Of Options

Please -- Do Not Take Medicine Into Your Own Hands, You Are NOT Out Of Options

Do-It-Yourself Treatments Could Be Fatal…… You are NOT out of options……………………… During these unprecedented times, we understand the patient’s frustration and how this pandemic has created a halt to the readily accessible alternative treatment option in the FMT community.   The need for continued treatments for a C. diff. infection and recurrent C. diff. infections are real and necessary. We also…

[rootsanalysis-blog]

Human Microbiome-based Products Market is projected to be worth USD 4 Billion by 2030, growing at an annualized rate of over 40%

Over the years, extensive R&D efforts have established the basis for a wide range of microbiome-based therapeutic and diagnostic products, which may cause a paradigm shift in the way healthcare is delivered in the foreseen future

 Roots Analysis has announced the addition of “Human Microbiome Market, 2019-2030” report to its list of offerings.

 The concept of microbiome-based therapeutics has generated significant enthusiasm within the medical science community, defining a new frontier in the field of medicine. Despite having captured the interest of several venture capital firms and big pharma players, no microbiome-based therapeutic has been officially approved by an authorized medical product regulator. However, the current development pipeline of microbiome therapeutics has several promising candidates that are likely to result in commercial success stories soon.

 To order this 640+ page report, which features 235+ figures and 275+ tables, please visit this - https://www.rootsanalysis.com/reports/view_document/human-microbiome-market/281.html

 Key Market Insights

 260 therapy candidates are currently in different phases of development

Nearly 25% of pipeline drugs are in the clinical phase of development, while the rest are in the preclinical / discovery stage. Interestingly, most of these drugs target digestive and gastrointestinal disorders (20%); this is followed by product candidates intended for treatment of oncological disorders (17%) and infectious diseases (13%).

 Over 30 microbiome diagnostic tests are currently available / under development

Around 30% of the abovementioned tests have been commercialized, while the rest are under development. Of the total tests, notable examples of companies that launched a microbiome-based diagnostic solution include (in alphabetical order) ARTPred, Genetic Analysis, Goodgut, Invivo Healthcare, IS-diagnostics, Luxia Scientific and Varinos.

 FMTs are the only commercially available microbiome therapy

This therapeutic product is presently indicated for the treatment of recurrent Clostridium difficile infections (rCDIs). Further, non-industry players (such as University of Alberta, The Second Hospital of Nanjing Medical University, University of California and Chinese University of Hong Kong) are making notable contributions in this arena, having been involved in ~200 clinical trials till August 2019.

 51% growth in capital investments has been observed since 2015; around 70% investment has come from Venture Capital investors

It is worth noting that more than 80 investors have supported the R&D programs initiated by start-ups focused on microbiome-related products.  Well-funded start-ups have initiated product development programs, having invested significant time and effort to explore the applicability of microbiome therapeutics across various indications.

 North America and Europe are anticipated to capture over 85% of the market share by 2030

As late stage products are commercialized, the microbiome therapeutics market is likely to grow at an annualized growth rate of over 30%, during the next decade. In addition to North America and Europe, the market in China / broader Asia Pacific region is also anticipated to grow at a relatively faster rate.

 To request a sample copy / brochure of this report, please visit this- https://www.rootsanalysis.com/reports/281/request-sample.html

 Key Questions Answered

§  Who are the leading developers of microbiome therapeutics and diagnostic tests?

§  What are the key technology platforms (available / under development) for microbiome-related therapies and diagnostics?

§  What are the disease indications against which microbiome-based therapeutics are being evaluated?

§  Which companies are targeting gut-brain axis for the development of microbiome therapies?

§  Who are the leading (industry and non-industry) players involved in the development of FMT products?

§  Who are the key contract research / manufacturing service providers in this domain?

§  What is the trend in capital investments in microbiome-related R&D?

§  What are the contributions of big pharma players in this domain?

§  Which are the popular players offering big data-related services / tools to support microbiome research?

§  How is the current and future market opportunity for microbiome-based therapeutics and diagnostics is likely to be distributed across key market segments?

  The USD 4 billion (by 2030) financial opportunity within the microbiome therapeutics (Tx) market and diagnostics (Dx) markets, has been analyzed across the following segments:

§  Type of Therapy (Tx)

§  Prescription Drug

§  Prebiotics

§  Probiotics

 §  Type of Molecule (Tx)

§  Small Molecules

§  Biologics

 §  Target Indication (Tx+Dx)

§  Acne Vulgaris

§  Atopic Dermatitis

§  Clostridium difficile Infection

§  Colorectal Cancer

§  Crohn’s Disease

§  Diabetes

§  Irritable Bowel Syndrome

§  Lactose Intolerance

§  Lung Cancer

§  Nonalcoholic steatohepatitis (NASH)

§  Obesity

§  Ulcerative colitis

 §  Therapeutic Area (Tx+Dx)

§  Autoimmune Disorders

§  Dental Disorders

§  Digestive and Gastrointestinal Disorders

§  Dermatological Disorders

§  Infectious Disease

§  Metabolic Disorders

§  Oncology

§  Others

 §  Key Geographical Regions (Tx+Dx)

§  North America

§  Europe

§  Asia-Pacific and Rest of the World

 The report features inputs from eminent industry stakeholders, according to whom innovation in microbiome-related research is mostly being driven by start-ups / small-sized companies. The report includes detailed transcripts of discussions held with the following experts:

§  Veronika Oudova (Co-founder and Chief Executive Officer, S-Biomedic)

§  Colleen Cutcliffe (Co-founder and Chief Executive Officer, Whole Biome)

§  Lee Jones (President and Chief Executive Officer, Rebiotix)

§  Mark Heiman (Chief Scientific Officer and Vice President, Research, MicroBiome Therapeutics)

§  Assaf Oron (Chief Business Officer, BiomX)

§  Pierre-Alain Bandinelli (Chief Business Officer, Da Volterra)

§  Nikole E Kimes (Co-founder and Vice President, Siolta Therapeutics)

§  James Burges (Executive Director, OpenBiome)

§  JP Benya (Vice President, Business Development, Assembly Biosciences)

§  Debbie Pinkston (Vice President, Sales and Business Development, List Biological Laboratories)

§  Gregory J Kuehn (Vice President, Business Development and Marketing, Metabiomics)

§  Alexander Segal (Vice President, Business Development, Universal Stabilization Technologies)

§  Alexander Lin (Associate General Manager, Chung Mei Pharmaceutical)

§  Aaron Wright (Senior Scientist, Pacific Northwest National Laboratories)

 The research covers detailed profiles, featuring a brief company overview, its financial information (if available), product portfolio details (such as status of development of pipeline candidates, clinical trial information and analysis of key trial end-points), recent developments and an informed future outlook.

§  4D Pharma

§  Armata Pharmaceuticals

§  Evelo Biosciences

§  Rebiotix (Acquired by Ferring Pharmaceuticals)

§  Seres Therapeutics

§  Vedanta Biosciences

 For additional details, please visit 

https://www.rootsanalysis.com/reports/view_document/human-microbiome-market/281.html or email sales@rootsanalysis.com

 You may also be interested in the following titles:

1.     Antibody Drug Conjugates Market (5th Edition), 2019-2030

2.     Gene Therapy Market (3rd Edition), 2019 - 2030

3.     Global T-Cell (CAR-T, TCR, and TIL) Therapy Market (4th Edition), 2019 – 2030

4.     Synthetic Lethality-based Drugs and Targets Market, 2019-2030

 Contact:

Ben Johnson

+1 (415) 800 3415

+44 (122) 391 1091

Ben.johnson@rootsanalysis.com

[66butch]

Appeals court orders patent owner to pay defense legal fees

Enlarge

The top US patent court has ordered a patent-holding company with a habit of dismissing cases rather than arguing its case in court to pay its opponent's attorneys fees.

A three-judge panel of judges on the US Court of Appeals for the Federal Circuit overruled (PDF) a federal judge in the Eastern District of Texas who allowed Rothschild Connected Devices Innovations LLC (RCDI) to walk away without paying legal fees of the company it had sued, ADS Security.

RCDI, owned by inventor Leigh Rothschild, claimed that ADS infringed his US Patent No. 8,788,090, which described a "system and method for creating a personalized consumer product." This patent originated with a 2006 application that describes a Star Trek-like Internet drink mixer.

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[healthnewstop]

Single fecal transplant no more effective than standard of care in treating C. diff

Toronto – Researchers at the University Health Network have found that when treating recurrent Clostridium difficile infection (RCDI), a single fecal transplantation delivered by enema is no more effective than the existing standard of care for RCDI, administration of oral vancomycin taper. The ... Source:Single fecal transplant no more effective than standard of care in treating C. diff

[healthtimetaylor]

Fecal microbiota transplantation as an effective initial therapy for pancreatitis complicated with severe Clostridium difficile infection.

PMID:  World J Clin Cases. 2019 Sep 6 ;7(17):2597-2604. PMID: 31559298 Abstract Title:  Fecal microbiota transplantation as an effective initial therapy for pancreatitis complicated with severeinfection: A case report. Abstract:  BACKGROUND: Moderately severe acute pancreatitis (MSAP) is a critical form of acute pancreatitis that is related with high morbidity and mortality. Severeinfection (sCDI) is a serious and rare nosocomial diarrheal complication, especially in MSAP patients. Fecal microbiota transplantation (FMT) is a highly effective treatment for refractory and recurrent CDI (rCDI). However, knowledge regarding the initial use of FMT in patients suffering from sCDI is limited.CASE SUMMARY: Here, we report an MSAP patient complicated with sCDI who was treated by FMT as a first-line therapy. The patient was a 51-year-old man who suffered from diarrhea in his course of acute pancreatitis. An enzyme immunoassay was performed to detect toxins, and the result was positive for toxin-producingand toxin B and negative forribotype 027. The colonoscopy revealed pseudomembranous colitis. Due to these findings, sCDI was our primary consideration. Because the patient provided informed consent for FMT treatment, we initially treated the patient by FMT rather than metronidazole. Diarrhea resolved within 5 d after FMT. The patient remained asymptomatic, and the follow-up colonoscopy performed 40 d after discharge showed a complete recovery. Our case is the first reported in China.CONCLUSION: This case explores the possibilities of initially using FMT to treat severe CDI. Moreover, FMT may become a critical component of the treatment for severe CDI in MSAP patients.

read more

[jesseneufeld]

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

[cdifffoundation]

Destiny Pharma Update On the Acquired NTCD-M3 Biotherapeutic Clinical Program For Prevention of Recurrence of C. diff. Infections (rCDI)

Destiny Pharma Update On the Acquired NTCD-M3 Biotherapeutic Clinical Program For Prevention of Recurrence of C. diff. Infections (rCDI)

Update on the recently acquired NTCD-M3 biotherapeutic clinical programme for prevention of recurrence of C. difficile infections Press release by Destiny Pharma: Brighton, United Kingdom – 22 December 2020: Destiny Pharma plc (AIM: DEST) a clinical-stage innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections, announces it is…

[66butch]

Patent troll with an “Internet Drink Mixer” and a nonexistent office could be in trouble

Enlarge (credit: USPTO)

This February, Garmin International got sued (PDF) by inventor Leigh Rothschild and his patent-holding company, Rothschild Connected Devices Innovations LLC (RCDI). RCDI had already sued 68 other companies. A few weeks later, Rothschild's lawyer got in touch. He wasn't interested in discussing the technology behind his client's two patents, which describe making customized mixed beverages. Instead, he asked Garmin to get on board with Rothschild's "early settlement program," for a fast payout of $75,000.

Garmin didn't pay up. Instead, the company's outside counsel Rachael Lamkin sent a letter to Rothschild's lawyer, explaining that his patents on a "system and method for creating a personalized consumer product" weren't valid, and ran afoul of Section 101 of the US Patent laws. That's the section that bars patents that are overly abstract, including "do it on a computer" type patents.

"Whether or not systems and methods for generating customized products are patent-eligible is a well-trodden question, repeatedly decided in the negative," Lamkin informed him, citing several earlier legal cases.

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