Fecal microbiota transplant has not been approved for ulcerative colitis, but off-label use is a possiblity.
Fecal microbiota transplantation (FMT) is an emerging treatment involving the transfer of healthful human microbiota into a patient via donor stool. FMT was recently approved to prevent the recurrence of Clostridioides difficile (C. difficile) infection in adults previously treated with antibiotics for recurrent C. difficile infection. The FMT product is available as an oral capsule and is marketed under the trade name Vowst by Seres Therapeutics, based in Cambridge, Massachusetts.
Although FMT is not currently approved to treat ulcerative colitis, some promising results have been reported. According to a group of researchers from the IMAGINE (Inflammation, Microbiome & Alimentation Gastro-Intestinal & Neuropsychiatric Effects) network led by Deborah A. Marshall, Ph.D., from the Cummings School of Medicine at the University of Calgary, the recent FDA approval may spur off-label use of FMT for treatment of other conditions, including active ulcerative colitis.
Marshall and her colleagues argue that knowing patient preferences regarding treatment options can help with shared decision-making and achieve patient-centered care that will improve treatment adherence and satisfaction.
To determine patient preferences for active ulcerative colitis treatments, especially preferecnes between biologics and FMT, the research group conducted a cross-sectional survey using discrete choice experiment surveys. The survey participants included Canadian adults with ulcerative colitis enrolled in the IMAGINE Chronic Disease Network’s Mind and Gut Interactions Cohort (MAGIC) study.
The study results were published recently in Therapeutic Advances in Chronic Disease.
The survey consisted of a series of scenarios in which respondents were asked to evaluate some attributes of treatment and choose their preferred scenario. The DCE included the following four attributes representing FMT and biologic treatments: chance of clinical remission, severity and chance of known side effects, severity and chance of rare unknown side effects, and what the administration of treatment would involve (oral capsule versus rectal enema or injection versus intravenous infusion).
The results showed that the chance of clinical remission was the most important attribute when participants were considering treatment preferences. This was followed by the severity of rare unknown side effects. Almost half (47.8%) of respondents were willing to try FMT, and oral administration was the preferred delivery method. When asked about their attitude toward the “ick factor” associated with a treatment derived from fecal matter, approximately 40% of participants said it was moderately to very important, while 40% indicated it was moderately to very unimportant.
About 27% of participants were focused on treatment effectiveness and benefit. This group was the youngest, had the shortest disease duration and indicated their most important attribute was chance of clinical remission. Close to 60% of the participants in this group were willing to undergo FMT, with nearly half giving the ick factor associated with the treatment a moderately to very unimportant rating.
The group of participants who rated the severity of rare unknown side effects as the most important attribute was the oldest and had the longest disease duration. The three-quarters (74.6%) of this group was in remission, and close to half indicated uncertainty about undergoing FMT. Just over half (52.2%) of this group gave the treatment ick factor a moderately to very important rating.
Understanding the characteristics of patients who are more likely to show interest in FMT may improve patient treatment adherence and satisfaction and optimize treatment efficacy, the authors concluded.
“Information about which patients may be more or less likely to take treatments with specific features can facilitate better informed decisions, satisfaction and adherence by personalizing treatment approaches that are aligned with patient preferences," wrote Marshall and her colleagues.
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