Tag Archives: American Gastroenterological Association

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

Centers for Disease Control and Prevention (CDC) Provides Updates On C. difficile Infection Management and Treatment

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According to the Centers for Disease Control and Prevention (CDC), Clostridium difficile infection (C. difficile) “has become the most common microbial cause of healthcare-associated infections in U.S. hospitals and costs up to $4.8 billion each year in excess health care costs for acute care facilities alone.”

Statistics provided by the CDC suggest that C. difficile cause nearly 500,000 infections in patients in the US annually.

In one study noted by the CDC, among infected patients, nearly 29,000 died within 30 days of being diagnosed, and more than half of those deaths (15,000) were directly attributable to C. difficile infection.

With C. difficile infection prevention being declared a national priority by the CDC, researchers, public health officials, infectious disease specialists, and others continue to research more effective ways to combat this microbe. Below, we’ve collected links and information on several recent developments.

THE GOOD NEWS
The Center for Infectious Disease Research and Policy (CIDRAP) recently -hospital-stewardship-lowers-antibiotic-use-infections”>reported some good news about the effectiveness of antibiotic stewardship programs (ASPs) in reducing antibiotic usage, especially among patients in the intensive care unit.

Citing the results of a meta-analysis published in Antimicrobial Agents and Chemotherapy, the CIDRAP report noted that, following the implementation of an ASP, “hospital antimicrobial consumption across all studies declined by 19.1%, and antibiotic costs fell by 33.9%. Though a modest decrease of 12.1% in antimicrobial use occurred in general medical wards, antimicrobial use in ICUs fell by 39.5% across the four studies that looked at that parameter.”

The meta-analysis also found that ASPs were effective in curbing the use of non-antibiotic therapies. In the six studies that also monitored antifungal prescription rates, the authors reported a 39.1% decline after ASP initiation.

The use of third- and fourth generation antibiotics (such as cephalosporins, vancomycin, tigecycline, linezolid, imipenem, meropenem, and fluoroquinolones) declined by 26.6% in facilities that implemented an ASP.

The meta-analysis found that bacteria infection rates declined 4.5% in the studies that measured clinical outcomes, and length of hospital stay fell by nearly 9% in studies that measured that metric.

However, the CIDRAP report noted that ASP implementation was not “associated with declining risks for Clostridium difficile (C diff) infections.” The authors of the meta-analysis did note that, in three studies that evaluated C difficile rates, “significant publication bias favored studies that reported ASPs’ negative effects.”

Let’s just get right to the heart of this report from Reuters:

“Fifteen years after the U.S. government declared antibiotic-resistant infections to be a grave threat to public health, a Reuters investigation has found that infection-related deaths are going uncounted, hindering the nation’s ability to fight a scourge that exacts a significant human and financial toll. Even when recorded, tens of thousands of deaths from drug-resistant infections – as well as many more infections that sicken but don’t kill people – go uncounted because federal and state agencies are doing a poor job of tracking them.

The Centers for Disease Control and Prevention (CDC), the go-to national public health monitor, and state health departments lack the political, legal and financial wherewithal to impose rigorous surveillance.”

The report goes on to outline how incomplete, “patchwork” infection reporting requirements for hospitals, and lax requirements in many states regarding physicians’ responsibilities when filling out death certificates, have led to deaths caused by (or at the very least associated with) MRSA and other drug-resistant pathogens to be “grossly under-reported.”

For example, according to Reuters, only 17 states require notification of C. difficile infections. Only two of the so-called “superbug” infections (MRSA bacteremia and C. difficile) are required to be reported to the CDC’s National Healthcare Safety Network surveillance program.

As they say, read the whole thing.

The authors of an article published in Clinical Microbiology and Infection  reported on a study that compared treatment with tigecycline to standard therapy in adult patients with severe C. difficile infection (sCDI).

The retrospective cohort study compared outcomes in patients with sCDI who received tigecycline alone to outcomes in patients who received standard oral vancomycin combined with intravenous metronidazole.

The primary study outcome was clinical recovery (as determined by European Society of Clinical Microbiology and Infectious Diseases guidelines); secondary outcomes were “in-hospital and 90-day all-cause mortality and relapse, colectomy and complication rates.”

A total of 90 patients with sCDI were treated (45 in each group). Patients treated with tigecycline monotherapy tended to do better in terms of cure rate, complicated disease, and CDI sepsis.

The authors reported that, compared to the group that received standard therapy, the tigecycline group had “significantly better outcomes of clinical cure (34/45, 75.6% vs. 24/45, 53.3%; p=0.02), less complicated disease course (13/45, 28.9% vs. 24/45, 53.3%; p=0.02) and less CDI sepsis (7/45, 15.6% vs. 18/45, 40.0%; p=0.009).”

Rates of mortality, disease relapse, and other measures were similar between the groups.

These results led the researchers to conclude that “tigecycline might be considered as a potential candidate for therapeutic usage in cases of sCDI refractory to standard treatment.”

Our good friends at Contagion Live recently reported on a study that has uncovered how the C. difficile bacteria produces toxins, which could aid the development of nonantibiotic drugs to fight C. difficile infection.

According to Contagion Live, C. difficile produces two toxins, toxin A and toxin B, that “cause life-threatening diarrhea as well as pseudomembranous colitis, toxic megacolon, perforations in the colon, sepsis and rarely death.”

Researchers at the University of Texas found that strains of C. difficile with a mutation in a particular Agr locus in their genome could not produce the toxins.

“Identifying a pathway responsible for activating the production of the toxins… opens up a unique therapeutic target for the development of a novel nonantibiotic therapy for C. difficile infections,” said the study authors.

The Contagion Live article includes a quote from author Charles Darkoh, PhD, on the potential implications of these findings.

“By crippling their toxin-making machinery, C. diff cannot make toxins and thus cannot cause disease. My laboratory is already working on this and was awarded a 5-year National Institutes of Health grant to investigate and develop an oral compound we have identified that inactivate the toxins and block the toxin-making machinery of C. diff by targeting this pathway,” he said.

 

 

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

 http://www.hcplive.com/medical-news/latest-news-and-updates-on-c-difficile-infection-management-and-treatment/P-4#sthash.iDm6FgAP.dpuf

 

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

What is a B.R.A.T. Diet ?

BRATdiett

The BRAT diet (Bananas, Rice, Applesauce, Toast) was once a staple of most pediatricians’ recommendations for children with an upset stomach. The idea was that it gave the gut a chance to rest and reduced the amount of stool produced. Now experts say the BRAT diet may not be the best option for children.

Because BRAT diet foods are low in fiber, protein, and fat, the diet lacks enough nutrition to help a child’s gastrointestinal tract recover. The American Academy of Pediatrics now recommends that kids resume eating a normal, well-balanced diet appropriate for their age within 24 hours of getting sick. That diet should include a mix of fruits, vegetables, meat, yogurt, and complex carbohydrates.

Both children and adults need to drink plenty of fluids while they’re sick to prevent Dehydration   Water is good, but adding broth, a sports drink, or a re-hydration solution can help replace lost electrolytes.

Call your health care provider and/or seek medical attention if you or your child experiences any of the following:

  • Diarrhea continues for more than two days
  • Poor Fluid Intake or unable to maintain adequate hydration
  • A temperature of 102 degrees Fahrenheit or higher
  • Reduced urine output
  • Light-headedness
  • No tears or sunken cheeks

 

Resource:  WebMD

American Gastroenterological Association (AGA) for Fecal Microbiota Transplantation Information

The American Gastroenterological Association (AGA) provides information to both physicians, and patients regarding  fecal microbiota transplantation (FMT).

Visit the AGA FMT website: http://fmt.gastro.org for more detailed information.