Based on a synthesis of best available evidence, the American Gastroenterological Association (AGA) has released clinical recommendations on fecal microbiota-based therapies (FMT) in adults with gastrointestinal diseases.
Addressing Clostridium difficile infection (CDI), Crohn’s disease (CD), ulcerative colitis (UC), pouchitis, and irritable bowel syndrome (IBS), the guidance supports FMT for the prevention of recurrent CDI but not for inflammatory bowel disease (IBD) or IBS — outside of clinical trials.
The AGA’s recommendations were published in Gastroenterology.
“Fecal microbiota–based therapies are effective therapy to prevent recurrent C. difficile in select patients,” the AGA guideline states. “Conventional fecal microbiota transplant is an adjuvant treatment for select adults hospitalized with severe or fulminant C. difficile infection not responding to standard of care antibiotics. Fecal microbiota transplant cannot yet be recommended in other gastrointestinal conditions.”
“We thought it was important to write this guideline because of the growing number of trials of FMT in IBD and IBS populations. It was also important with the new FDA-approved treatments on the market,” the guideline’s first author, Anne F. Peery, MD, MSCR, AGAF, told this news organization, noting that the recently approved products did not yield better results than those of conventional rectal FMT. “The guidelines will help clinicians understand the available therapies and how to use these treatments,” added Dr Peery, associate professor in the Division of Gastroenterology and Hepatology at the University of North Carolina School of Medicine in Chapel Hill.
Although the existing evidence is of low or very low certainty, Dr Peery acknowledged, gastroenterologists “should be comfortable with conventional FMT and also the new FDA-approved products. We spent a considerable amount of time developing implementation considerations, which is practical advice to help clinicians use the guideline recommendations.”
Designed to counteract intestinal dysbiosis and restore protective gut flora, the FMT approach includes conventional, colonoscopically delivered donor stool transplants, as well as two newly approved options: Rectally given fecal microbiota (live-jslm/ Rebyota) and most recently, orally delivered fecal microbiota spores (live-brpk/ Vowst).
The AGA urges careful pretreatment consideration for patients who require frequent antibiotics or long-term antibiotic prophylaxis since ongoing antibiotics may diminish the efficacy of FMT.
The guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation framework to prioritize clinical questions, identify patient-centered outcomes, and conduct an evidence synthesis, followed by the Evidence-to-Decision framework to develop recommendations for these therapies and algorithms for their implementation into clinical practice.
Recommendations
The eight-member panel suggested the following practices on behalf of the AGA Clinical Guidelines Committee:
In immunocompetent adults with recurrent CDI, select use of FMT can be used after completion of standard-of-care antibiotics to prevent recurrence. It can be considered after the second recurrence (episode 3) of CDI or in select patients at high risk for either recurrent CDI or a morbid CDI recurrence. Recurrent CDI is defined as clinically significant diarrhea ≥ 3 unformed stools in 24 hours with a confirmatory positive test within 8 weeks of completing antibiotics. Select use includes patients who have recovered from severe, fulminant, or particularly treatment-refractory CDI and patients with significant comorbidities. Severe CDI involves a leukocyte count of ≥ 15 × 109 cells/L and/or creatinine ≥ 1.5 mg/dL, while fulminant CDI involves shock, ileus, or megacolon and can be fatal.In mildly or moderately immunocompromised adults with recurrent CDI, the guidance recommends select use of conventional fecal microbiota transplant.In severely immunocompromised adults or those undergoing cytotoxic treatment, the AGA advises against the use of any fecal microbiota-based therapies to prevent recurrent CDI.Conventional FMT is not advised in patients who have bowel perforation or obstruction or are severely immunocompromised.For CDI patients not interested in FMT, reasonable alternatives to prevent recurrence are a vancomycin taper, tapered-pulsed fidaxomicin, or bezlotoxumab.In adults hospitalized with severe or fulminant CDI not responding to standard-of-care antibiotics, the AGA recommends select use of conventional FM transplant.In the current absence of evidence, the guidance advises against the use of conventional fecal microbiota transplant as treatment for IBD or IBS except in the context of clinical trials.
“We felt the data for using FMT in the treatment of UC was promising, but there is still a lot more work to be done in IBD and IBS,” Dr Peery said. For each disease section the guideline outlined directions for future research. It will be updated in 3-5 years as more evidence becomes available.
This guideline was fully funded by the AGA Institute. Dr Peery and fellow panel member Dr Benjamin Lebwohl are supported by grants the National Institute of Diabetes and Digestive and Kidney Diseases. Panel member Colleen R. Kelly, MD, is supported by the National Institute of Allergy and Infectious Diseases.
None of the panel members had any conflicts of interest to report.
This article originally appeared on MDedge.com, part of the Medscape Professional Network.
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