Fecal Microbiota Transplantation Being Studied for IMIDs

Inflammatory bowel disease (IBD) disrupts the human gut microbiome, which Jessica Allegretti, MD, described to the virtual Interdisciplinary Autoimmune Summit 2020 as “an ecologic community of commensal, symbiotic, and pathogenic microorganisms that literally share our body space.”

Jessica Allegretti, MD, is codirector of the Crohn’s and Colitis Center at Brigham and Women’s Hospital in Boston, Massachusetts, where she also serves as director of the fecal microbiota transplantation (FMT) program.

Experience with the success of FMT in treating recurrent Clostridiodes difficile infection (CDI) has led to increasing interest in FMT as a possible treatment for IBD.

At present FMT is considered by the US Food and Drug Administration (FDA) as both a drug and a human tissue, cell, or biologic product. Although FMT is not approved, the agency allows FMT to be applied in cases of recurrent or severe, complicated CDI with appropriate informed consent of the patient.

The use of FMT should follow the “Five Ds,” Dr Allegretti explained, the first of which is decision—the choice of patients who qualify as candidates for FMT. The second D is donor selection. Although patients can choose a donor, FMT increasingly relies on the stool bank model, which maintains healthy donor stool. This model is more efficient and has a proven track record of donor screening, she said.

Next is discussion, in which the physician informs the patient about the possible risks of the procedure.

The third is delivery, which may be done via nasogastric tube; however, in the United States, FMT is more often delivered by retention enema, lower endoscopy, or by encapsulation. Dr Allegretti prefers the lower endoscopic method of delivery in most patients.

Following delivery, patients are followed for 8 weeks during the discharge period to assess for any recurrence of CDI. In most cases, patients who have recurrent CDI are brought back for a second course of treatment.

Whether FMT can be efficacious in treating immune-mediated diseases, including Crohn disease and ulcerative colitis, remains in question. Dr Allegretti stated that in 3 of 4 randomized clinical trials of FMT in the treatment of UC resulted in overall remission of 28% vs 9% for placebo. “This puts FMT on par with biologics in clinical trials for treatment of UC.” The results in treating Crohn disease are less significant, though one patient in a very small study showed complete remission at 12 weeks post-FMT, she noted.

Based on data from the largest prospective trial to date, "the safety and efficacy of FMT are better than has been shown in previous reports, " Dr Allegretti stated. She added that the primary stool bank, Openbiome, has always tested for multidrug resistant organisms, which is often a major concern with

The health of the gastrointestinal system affects more than the gut itself, she explained, noting that rheumatoid arthritis, asthma, multiple sclerosis, and others appear to have a relationship to intestinal health. In response to a question, Dr Allegretti reported that almost 200 trials are now listed on clinicaltrials.gov in which FMT is being tested for a variety of conditions. Among the most promising is FMT’s application in treating alopecia, following reports of spontaneous hair regrowth in patients with this dermatological condition when they were treated with FMT for CDI recurrence.  

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—Rebecca Mashaw

Reference:

Allegretti J. Evolving role of fecal transplants in IMID. Talk presented at: Interdisciplinary Autoimmune Summit 2020; July 11, 2020; virtual.