Tag Archives: Fecal Microbiota Transplantation

The American Gastroenterological Association (AGA) Fecal Microbiota Transplantation (FMT) National Registry Enrolls First Patient

Largest planned fecal microbiota transplantation (FMT) study enrolls first patient

The FMT National Registry also announces collaborations with American Gut and OpenBiome

The first participant has enrolled in the American Gastroenterological Association (AGA) Fecal Microbiota Transplantation (FMT) National Registry, which is planned to be the largest FMT study ever.

The AGA FMT National Registry — funded by the National Institutes of Health (NIH) and administered by the AGA Center for Gut Microbiome Research and Educationwill track 4,000 patients for 10 years after their FMT procedure, providing a wealth of data about the procedure’s effectiveness and both short- and long-term effects of FMT.

Fecal microbiota transplant is a medical procedure in which the stool from a healthy person is prepared and then put into the intestine of a sick patient. FMT is most commonly used to treat Clostridium difficile (C. diff) infection, if antibiotics have not been able to get rid of the infection.

“Today is an important milestone for the AGA FMT National Registry. What’s ahead is a significant repository of data for investigators working to advance FMT research, better information for physicians on when and how to use FMT, and reassurance for patients that we now understand the risks and benefits of this procedure,” said Gary D. Wu, MD, a principal investigator for the registry and founding chair of the AGA Center for Gut Microbiome Research and Education scientific advisory board. “We look forward to embarking on this comprehensive data collection project and are eager to share our findings with the public.”

First Patient Enrolled

The first patient enrolled in the FMT National Registry received a fecal transplant through the Gastroenterology Center of Connecticut/Medical Research Center of Connecticut by Paul Feuerstadt, MD, assistant clinical professor of medicine at Yale School of Medicine, New Haven, CT. The patient being treated had experienced multiple recurrences of C. difficile infection. As part of the registry,

Dr. Feuerstadt will follow up with the patient four times over the next two years and report back on the patient’s health post-FMT. The patient will also provide yearly reports for up to 10 years.

How Patients Can Take Part in the FMT National Registry

AGA expects 75 sites to be included in this registry. Visit ClinicalTrials.Gov <https://clinicaltrials.gov/ct2/show/study/NCT03325855?cond=FMT+National+registry&rank=1> on a regular basis to track new sites added to the registry. Patients should reach out to their health care provider to discuss participation in the registry.

Patients should first review AGA’s patient information on fecal microbiota transplantation (FMT) <http://www.gastro.org/info_for_patients/clostridium-difficile-106-fmt-details>.

UC San Diego to Build FMT National Registry Biobank

AGA is collaborating with the American Gut Project — an academic effort run by the laboratory of Rob Knight, PhD, professor and director of the Center for Microbiome Innovation at the University of California, San Diego — to build a biobank of stool samples from participants in the FMT National Registry. American Gut will receive stool samples from registry participants before and after their FMT. The microbiota will be sequenced in each sample, and remaining material will be frozen to be made available for future research. Eventually, this information could help doctors screen and select the best donor samples for individual patients.

OpenBiome Joins as a Registry Collaborator

AGA is also collaborating with OpenBiome, a public stool bank and nonprofit research organization that provides clinicians with rigorously screened, ready-to-use stool preparations for fecal transplant procedures. As the only public stool bank in the country, OpenBiome serves as the source of stool preparations for nearly 1,000 clinical partners performing FMT across the United States. For patients enrolled in the registry who receive OpenBiome FMT material, OpenBiome will provide screening information and samples to support the registry’s research analyses.

To read this article in its full entity, please click on the following link to be redirected:

https://www.eurekalert.org/pub_releases/2018-01/aga-lpf010918.php

Fecal Microbiota Transplantation – Regulatory Harmonization Is Lacking

 

 

 

Abstract

During faecal microbiota transplantation, stool from a healthy donor is transplanted to treat a variety of dysbiosis-associated gut diseases.

Competent authorities are faced with the challenge to provide adequate regulation. Currently, regulatory harmonization is completely lacking and authorities apply non-existing to most stringent requirements.

A regulatory approach for faecal microbiota transplantation could be inserting faecal microbiota transplantation in the gene-, cell- and tissue regulations, including the hospital exemption system in the European Advanced Therapy Medicinal Products regulation, providing a pragmatic and efficacy-risk balanced approach and granting all patients as a matter of principle access to this therapy.

https://www.ncbi.nlm.nih.gov/pubmed/29179687?dopt=Abstract&utm_source=dlvr.it&utm_medium=twitter

Patient and Healthcare Provider Information For Fecal Microbiota Transplantation (FMT)

For patients searching for physicians participating in  Fecal Microbiota Transplantations

The American Gastroenterological Association (AGA) website hosts a complete page with

full coverage and information pertaining to this subject.

Please click on the link below to be directed to the AGA website to assist you.  Thank you

http://fmt.gastro.org/find-a-practitioner/

 

Note:  This treatment – in any form – has not yet been approved by the
U.S. Food and Drug Administration (FDA).

Clinical data is pending and FMT remains investigational at this time

and Clinical studies are in progress.

For updates visit the US Food and Drug Administration website:

http://www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/vaccines/ucm387023.htm

Fecal Microbiota Transplantation (FMT) A Promising Treatment And Recurrent C diff Infections

NurseCadeceus

The media and publications are raising
FMT awareness .

The positive effects are being
noted as FMT’s hold a promising treatment option and success is being witnessed in patients suffering
through C. diff. infections.

Being treated  by a physician with a Fecal Microbiota Transplantation, to treat recurrent Clostridium difficile infections, is resolving the pain and torment being experienced by patients.

What is a Fecal Microbiota Transplant (FMT)?

Fecal microbiota transplants (FMTs) are exactly what they sound like.
They involve taking feces from a healthy person and putting them into the body
of a sick patient to strengthen the community of bacteria that live in the patient’s gut.
FMTs are very effective at curing stubborn infections with Clostridium difficile (C. diff).

The deadly bacteria cause 500,000 illnesses and 14,000 deaths each year in the United States. Small studies have shown that FMTs can cure about 90 percent of serious C. diff infections. They have been so successful that scientists are testing the transplants for other conditions, such as irritable bowel syndrome. (1)

However; this treatment – in any form – has not yet been approved by the
U.S. Food and Drug Administration (FDA).

Clinical data is pending and FMT remains investigational at this time.

Below is the link to the FDA website and the March 2014 document regarding
Fecal Microbiota Transplantation (FMT) for the general public:

III.  When FDA Intends to Exercise Enforcement Discretion 

FDA does not intend to exercise enforcement discretion for the use of an FMT product when the FMT product is manufactured from the stool of a donor who is not known by either the patient or the licensed health care provider treating the patient, or when the donor and donor stool are not qualified under the direction of the treating licensed health care provider.
FDA will continue to evaluate its enforcement policy.
Furthermore, during the period of enforcement discretion, FDA will continue to work with sponsors who intend to submit INDs for use of FMT to treat C. difficile infection not responding to standard therapies.
This enforcement discretion policy does not extend to other uses of FMT.  Data related to the use and study of FMT to treat diseases or conditions other than C. difficile infection are  more limited, and study of FMT for these other uses is not included in this enforcement policy.  (2)
* Also, click on the link below to view the US Food and Drug Administration (FDA)
Upcoming Workshop Information:
**  Always discuss treatment options available with a Healthcare provider
and review/discuss clinical studies in progress.
Resources:

Comparison Study Shows Efficacy in Frozen Fecal Product To Fresh For Fecal Microbiota Transplantation To Treat Recurrent C. diff. Infections

Frozen fecal microbiota transplantation showed efficacy comparable to fresh FMT for clinical resolution of diarrhea among adult patients with recurrent or refractory Clostridium difficile infection, according to results of a randomized trial published in JAMA.

Using frozen FMT would reduce costs associated with donor screening frequency, provide immediate availability of the treatment and enable delivery of the treatment to centers without on-site laboratory facilities,

the researchers wrote. “Previous studies have supported the use of frozen FMT for management of recurrent [C. difficile infection] but have not directly compared frozen with fresh FMT.”

Lee CH, et al. JAMA. 2016;doi:10.1001/jama.2015.18098

Malani PN, Rao K. JAMA. 2016;doi:10.1001/jama.2015.18100

Christine H. Lee, MD, from McMaster University in Canada, and colleagues, conducted a double-blind, noninferiority trial involving 232 adult patients with recurrent or refractory C. difficile infection (CDI) at six Canadian academic medical centers from July 2012 to September 2014. Patients were randomly assigned to receive frozen (n = 114) or fresh (n = 118) FMT via enema without bowel preparation, and if they showed no improvement by day 4, they received an additional FMT between days 5 and 8.

No recurrence of CDI-related diarrhea at 13 weeks and adverse events served as primary outcomes, and a 15% margin was set to confirm noninferiority.

In the per-protocol population (frozen, n = 91; fresh, n = 87), 83.5% of the frozen FMT group achieved clinical resolution compared with 85.1% of the fresh FMT group, a difference of – 1.6% (95% CI, – 10.5% to ∞; P = .01 for noninferiority). In the modified intention-to-treat population (frozen, n = 108; fresh, n = 111), 75% of the frozen FMT group achieved clinical resolution compared with 70.3% of the fresh FMT group, a difference of 4.7% (95% CI, – 5.2% to ∞; P < .001 for noninferiority). Adverse and serious adverse events were comparable between groups; the most common adverse events were transient diarrhea (70%), abdominal cramps (10%) or nausea (< 5%) during the 24 hours after FMT, and constipation (20%) and excess flatulence (25%) during follow-up, all mild to moderate in severity.

“Among adults with recurrent or refractory CDI, the use of frozen compared with fresh FMT did not result in worse proportion of clinical resolution of diarrhea,” the researchers concluded. “Given the potential advantages of providing frozen FMT, its use is a reasonable option in this setting.”

These researchers have provided

“the best evidence to date supporting the use of frozen stool, with their finding that use of frozen stool for FMT resulted in a rate of clinical resolution of diarrhea that was no worse than that obtained with fresh stool for FMT and will likely expand the availability of FMT for patients with recurrent CDI,”

Preeti N. Malani, MD, MSJ, associate editor of JAMA, and Krishna Rao, MD, MS, both from the University of Michigan Health System, Ann Arbor, wrote in a related editorial. “The ability to use frozen stool eliminates many of the logistical burdens inherent to FMT, because stool collection and processing need not be tied to the procedure date and time.

This study also provides greater support for the practice of using centralized stool banks, which could further remove barriers to FMT by making available to clinicians safe, screened stool that can be shipped and stored frozen and thawed for use as needed. In theory, procedure costs may also be decreased, since comprehensive donor screening is expensive.” – by Adam Leitenberger

Disclosures: Lee reports she has participated in clinical trials for ViroPharma, Actelion, Cubist and Merck, and served as a member of the advisory boards for Rebiotix and Merck. Please see the study for a full list of all other researchers’ relevant financial disclosures. Malani and Rao report no relevant financial disclosures.dR

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http://www.healio.com/gastroenterology/infection/news/online/%7Bbac5a422-a30c-4501-8e35-05e9a346772a%7D/frozen-fmt-noninferior-to-fresh-fmt-for-treating-recurrent-c-difficile-infection

C Diff Foundation Welcomes Dr. Caterina Oneto, MD

oneto_for_the_web

 

We are pleased to welcome Dr. Caterina Oneto, MD to the
C Diff Foundation. 

Dr. Oneto presides as a Medical Advocate for the  
C. diff. Nationwide Community Support Program teleconferencing sessions.

 

Cdiff2015CDNCSPostCard

 

Dr. Caterina Oneto is a Clinical Assistant Professor within the NYU Division of Gastroenterology, Board Certified in Gastroenterology and Internal Medicine. 

Fluent in Spanish, she graduated with a degree in Medicine and Surgery from the
Universidad de Valparaiso in Chile. She completed her residency in
Internal Medicine at Cabrini Medical Center, where she served also as Chief Resident, and later completed her Fellowship in Gastroenterology at Montefiore Medical Center, Albert Einstein College of Medicine. 

With expertise in endoscopy, colonoscopy, capsule endoscopy, liver and pancreatic diseases, Dr. Oneto’s special interests include IBD (Crohn’s disease and Ulcerative Colitis), IBS (irritable bowel syndrome), microbiota modification, treatment of Clostridium Difficile and FMT (Fecal Microbiota Transplantation). 

Scientific research demonstrates new evidence supporting Fecal Microbiota Transplant successful in treating C. difficile infections

Research published in the open access journal Microbiome offers new evidence for the success of fecal microbial transplantation (FMT) in treating severe Clostridium difficile infection (CDI), a growing problem worldwide that leads to thousands of fatalities every year.

Research led by Michael Sadowsky, Alex Khoruts, and colleagues at the University of Minnesota in collaboration with the Rob Knight Lab at the University of Colorado, Boulder, reveals that healthy changes to a patient’s microbiome are sustained for up to 21 weeks after transplant, and has implications for the regulation of the treatment. Findings also demonstrate the dynamic nature of fecal microbiota in FMT donors and recipients.

In FMT, fecal matter is collected from a donor, purified, mixed with a saline solution and placed in a patient, usually by colonoscopy. In contrast to standard antibiotic therapies                                (e.g., Vancomycin)  which further disrupt intestinal microflora and may contribute to the recurrence of CDI, FMT restores the intestinal microbiome and healthy gut function.

Using DNA samples of healthy individuals from the Human Microbiome Project (HMP) as a baseline, Sadowsky and his team compared changes in fecal microbial communities of recipients over time to the changes observed within samples from the donor. Significantly, the composition of gut microbes in the both donor and recipient groups varied over the course of the study, but remained within the normal range when compared to hundreds of samples collected by the HMP.

According to Sadowsky, the findings have important implications for a range of diseases associated with microbial imbalance, or dysbiosis, and could influence the regulatory regime surrounding FMT, currently treated as a drug by the U.S. Food and Drug Administration (USFDA).

“The dynamic nature of fecal microbiota in both the donor and recipients suggests that the current framework of regulation, requiring consistent composition, may need to be reexamined for fecal transplantations,” says Michael Sadowsky. “Change in fecal microbial composition is consistent with normal responsiveness to shifts in the diet and other environment factors. Variability should be taken into account when comparing microbial composition in normal individuals to those with dysbiosis characteristic of disease states, especially when assessing clinical interventions and outcomes.

Also discovered in the research, the performance of frozen and fresh preparations of fecal material was indistinguishable. Though the sample was limited and warrants further study with a larger cohort, it has several implications for the widespread adoption of FMT. The frozen preparation greatly simplifies the standardization and distribution of the fecal material. It also facilitates long-term storage of donor material for future study and makes FMT accessible to a greater number of physicians and patients. Finally, it offers advantages over fresh material in the testing of fecal samples for pathogens, which in some cases can take several weeks to complete.

While FMT is particularly successful in patients who suffer from recurrent CDI, University of Minnesota researchers led by Sadowsky and Dr. Alex Khoruts are currently preparing for a clinical trial using FMT to improve insulin sensitivity in pre-diabetic patients and to treat metabolic syndrome.

 

To read the article in its entirety please click on the following link:

http://www.eurekalert.org/pub_releases/2015-04/uom-nes040915.php