Tag Archives: FMT

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

Medicine, Like All Science, Is Dynamic and Forever Evolving and Why It Is Regarded As “The Practice Of Medicine.”

Medicine, like all science, is dynamic and evolving—that’s why it is referred to as “the practice of medicine.”

Accepted treatments of one era might be discarded later as “pseudoscience.” What is considered “experimental” today might become the standard of treatment tomorrow.

Fortunately, there is something called peer review and scientific standards. Also, most health care providers have embraced the process of gathering as much evidence as possible instead of treating patients like lab rats.

There is no safe substitute for the intimate, one-on-one relationship between a patient and a physician. This will continue to be true as long as doctors remember that medicine is a science and an art, full of both expected outcomes and surprising solutions.

The phrase “Nine out of 10 doctors recommend…” is often used to promote widely accepted treatments, so that one outlier doctor must be responsible for all the rather wacky treatments that we other physicians get asked about every week. And although some of these treatments seem beyond bizarre, they can also be incredibly interesting.

At least they were to the three physicians listed in this article’s byline, including
Dr. H. Eric Bender, who says his fascination with peculiar medical practices started in medical school. During one of his early rotations, he was shocked to learn that not only could he order leeches for a patient in the hospital but he could specify where they were to be placed as well: left leg, right arm or whole body. (In case you’re wondering, to precisely “aim” a leech, place it in a small cup with a very small hole cut in the bottom. That hole is then aligned with the area on the patient requiring blood removal and voilà! Bloodthirsty segmented worms are suddenly hard at work.
(Dr. Bender does not recommend trying this at home.)

Now, thanks to our internet-sparked society of do-it-yourselfers, Bender’s fascination with the unconventional cure has continued to grow as he has contemplated conversations with his patients and researched a wide range of (seemingly) ridiculous but sometimes effective remedies.
“Unfortunately, the physician’s oath to “do no harm” has been replaced in many
clinics with “do clean up this mess.”

For example, a physician or two in the not so distant past recommended that children smoke tobacco to treat pica, a condition in which people feel compelled to chew on non-nutritious substances like rocks, sand or glass. Some doctors over the years suggested that patients use cocaine and heroin to remedy toothaches and persistent cough, respectively. (In addition to references, the book includes pictures as evidence.) Alcohol has been recommended to pregnant women for its health benefits—Guinness beer is rich in iron—and not just by Irish physicians. Others practicing medicine have suggested using hookworms to cure asthma (causing dangerous infections).

The list of dangerous substances, organisms and animal byproducts that people have used over the years to treat everything from low libido to sexually transmitted diseases goes on and on. Fortunately, most of the practices did not, as further research demonstrated the dangers of many of them.

“Weird medicine” is not limited to just medical practices and treatments. A look into the medical literature reveals that it is replete with research and studies that aren’t particularly well-designed or are far-fetched to the point of absurdity.

Some fascinating practices seemed like terrible ideas but are actually so well-supported by research that they are considered the gold standard for treatment of certain illnesses.

As an example, consider that antibiotics frequently kill good bacteria while also killing the bad bacteria doctors are trying to eliminate.

“Good” bacteria suppress the growth of bad bacteria. So when the good bacteria are wiped out, many individuals develop a type of intestinal infection known as Clostridium difficile
(or C. diff
). C. diff is often difficult to treat with antibiotics, since they typically caused the problem in the first place. Fortunately, one treatment has a  high rate of s
uccess: fecal transplantation. Yes, you read that correctly. Doctors place stool from a donor inside the patient’s gastrointestinal system. Intuitively, you might think putting my feces into your gut would cause serious infections, but the donated good bacteria help eradicate infection.

To learn more about FMT:  https://cdifffoundation.org/2016/03/02/fecal-transplants-fmt-treating-clostridium-difficile-infections-u-s-food-and-drug-administration-fda-seeks-comment-on-what-investigational-new-drug-ind-requirements-to-waive/

IHow about maggots instead? Maggot therapy involves using those little legless larvae to prevent a wound infection. Maggots selectively target and eat dead tissue that is difficult to remove surgically without taking healthy tissue with it. Although doctors have been aware of this fact since at least the 1930s, this treatment was not regularly used for decades, particularly as antibiotic use to treat and manage wounds rose in popularity. However, after a recent “rediscovery” of maggot therapy, more than 800 health care institutions use it today. You can be sure pharmaceutical companies are already working on a way to charge exorbitant prices for the little larvae.

Patients performing their own research online can spark informative conversations with their doctors, even if they do sometimes suggest things that make a person want to scream, or puke.

Nevertheless, although “Dr. Google” is punctual and doesn’t require a co-pay, it is still not qualified to diagnose and treat.

There is no safe substitute for the intimate, one-on-one relationship between a patient and a physician. This will continue to be true as long as doctors remember that medicine is a science and an art, full of both expected outcomes and surprising solutions.

So to our patients: Be wary of charlatans but keep an open mind. Bring all your questions to a physician and ask away. To our fellow physicians: Listen to your patients. Talk with them, not to them. And remember: If you can’t do any good, at least do no harm.

 

H. Eric Bender, Murdoc Khaleghi and Bobby Singh are the authors of 1 Out of 10 Doctors Recommends: Drinking Urine, Eating Worms, and Other Weird Cures, Cases, and Research from the Annals of Medicine.

 

To read this article in its entirety, click on the link below:

http://www.newsweek.com/2016/08/26/weird-medicine-doctor-google-pseudoscience-491240.html

Fecal Transplants (FMT) Treating Clostridium difficile Infections; U.S. Food and Drug Administration (FDA) Seeks Comment on What Investigational New Drug (IND) Requirements To Waive

Fecal Transplants to Treat C. difficile: FDA Seeks Comment on What IND Requirements to Waive

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The US Food and Drug Administration (FDA) on Monday February 29, 2016,announced new draft guidance that aims to further assure that patients infected with the bacterium Clostridium difficile and not responding to standard therapies can access poop transplants, also known as fecal microbiota for transplantation (FMT).

FDA considers FMT an investigational new drug (IND), which requires physicians and scientists to file an IND application if they intend to use the treatment for clinical practice or research.

However, FDA has issued guidance stating that FMT may be used to treat 

C. difficile infection not responsive to standard therapies outside of a clinical trial. 

New Guidance

The latest draft guidance offers new notice that FDA intends to exercise enforcement discretion regarding the IND requirements for the use of FMT to treat C. difficile infection.

As far as what FDA wants to discuss on this new draft guidance, the agency says it’s requesting comments on which IND requirements are appropriate to waive.

In particular, FDA is requesting comments on the requirement for institutional review board review of the use of FMT to treat patients with C. difficile infection not responding to standard therapies when the FMT is provided by a stool bank,” FDA says.

Background

The draft guidance comes as over the past few years, FMT, which basically involves the transfer of a healthy donor stool to the bowel of a patient infected with C. difficile, has emerged as an effective means to treat recurrent forms of the bacterial infections, according to a study in the Journal of Law and Biosciences.

Rachel Sachs, an academic fellow at Harvard University’s Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics, and an author of that study, explained to Focus that previously FDA said it would regulate FMT like a biologic, but that the decentralized, hospital-based model of FMT envisioned in this new draft guidance more closely resembles the agency’s models for regulating tissue or cord blood products.

Two companies – Rebiotix and Seres Therapeutics – have been granted orphan drug designations for their INDs as FMT treatments for recurrent C. difficile infections, which affect between 85,000 and 110,000 people in the US annually.

And Sachs said she’s under the assumption that once a company gets FDA approval for their FMT product, FDA will revoke its enforcement discretion included in this new guidance.

Guidance Details

FDA said Monday it intends to use this discretion for waiving certain IND requirements, provided that:

  • The licensed health care provider treating the patient obtains consent from the patient or his or her legally authorized representative for the use of FMT products. The consent should include, at a minimum, a statement that the use of FMT products to treat C. difficile is investigational and a discussion of its reasonably foreseeable risks;
  • The FMT product is not obtained from a stool bank; and
  • The stool donor and stool are qualified by screening and testing performed under the direction of the licensed health care provider for the purpose of providing the FMT product for treatment of the patient.

And FDA makes clear that an establishment that collects or prepares FMT products “solely under the direction of licensed health care providers for the purpose of treating their patients (e.g., a hospital laboratory) is not considered to be a stool bank under this guidance.”

Sachs co-authored her article with Carolyn Edelstein, director of policy and global partnerships at OpenBiome, a nonprofit stool bank that sells FMT capsules (recommended dose of 30 capsules plus a safety test capsule costs $535, or stool preparations for delivery by colonoscopy, enema, and EGD/naso-enteric tube are $385 each) after conducting first-in-human evaluations (N=4) and a randomized dose-finding study (N=17).

Edelstein told Focus that the draft “suggests that the FDA is seeking to set up a more tailored regulatory scheme, one that considers stool banking separately from small-scale directed donation. We are in favor of seeing stool banking receive more regulatory oversight. We plan to answer the agency’s request for comments on the elements of a regulatory framework that would lend this oversight to the practice of stool banking without unduly burdening the physicians and healthcare facilities using banked material, and by extension, unduly limiting access to the treatment for their patients.”

FDA also explains that there were “difficulties in interpretation” with previous draft guidance, particularly around the provision that the donor be known either to the patient or to the treating licensed health care provider, noting “the revised approach more accurately reflects our intent to mitigate risk, based on the number of patients exposed to a particular donor or manufacturing practice rather than the risk inherent from any one donor.”

But as new FMTs are likely to hit the market as orphan drugs, the bigger issue at play could be associated with cost. Sachs noted that any FDA-approved treatment, particularly since it’s an orphan product, could be expensive (upwards of thousands of dollars for treatment).

 

Source:

http://www.raps.org/Regulatory-Focus/News/2016/02/29/24428/Fecal-Transplants-to-Treat-C-difficile-FDA-Seeks-Comment-on-What-IND-Requirements-to-Waive/

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

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

TO READ ARTICLE IN ITS ENTIRETY CLICK ON LINK BELOW:

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

UBiome and OpenBiome Partner in Microbiome Studies

The study will provide new insights on mechanics of fecal microbiota transplantation with patients being treated for a C. diff. infection.

uBiome and OpenBiome Partner for Microbiome Study in FMT Patients

Study will provide new insights on mechanics of fecal microbiota transplantation in patients treated for a C. difficile infection.

uBiome and OpenBiome announced a new partnership to study the microbiome of patients undergoing fecal microbiota transplantation (FMT) as a treatment for Clostridium difficile infections (C. diff).

Any patient undergoing clinical FMT treatment can request their complimentary mail-order microbiome testing kit at http://ubiome.com/pages/fmt. The kit allows them to swab a sample of their microbiome, which they send back to uBiome for analysis and sequencing. uBiome will use the collected data to conduct a study of FMT’s impact on the body’s microbiota. All study participants will also receive a detailed report on their personal microbiome.

“Because we will be looking at patients before, during, and after FMT we will be able to learn about how the microbiota adjusts to the treatment,” adds OpenBiome Co-Founder and President Dr. Mark Smith. “This has the potential to not only shed light on C. diff, but also open the door to using FMT with patients suffering other conditions.”

C. diff infections can occur when there is a severe imbalance of gut microbiota. Because of this imbalance, the bacterium thrives and causes extreme gastrointestinal distress.

This study will serve to increase awareness and understanding of how FMT affects the human microbiome, which could increase its acceptance in the medical community as a way to treat a potential variety of gastrointestinal conditions.

About uBiome:
uBiome (ubiome.com) sequences the microbiome for citizen scientists, researchers, and clinicians, using microbial genomics to help patients benefit from new discoveries in scientific research. uBiome conducts research studies on the microbiome and develops clinical diagnostics based on microbiome research.

About OpenBiome:
OpenBiome (openbiome.org) is a nonprofit stool bank dedicated to expanding safe access to fecal microbiota transplantation (FMT) therapies. Founded by a team of microbiologists, public health advocates, and concerned citizens, OpenBiome aims to significantly reduce the practical barriers for clinicians providing FMTs, while connecting scientists across studies and disciplines.

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

http://www.prweb.com/releases/2015/07/prweb12820941.htm

June 2015

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