Background & Aims Ulcerative colitis (UC) is difficult to treat, and standard therapy does not always induce remission. Fecal microbiota transplantation (FMT) is an alternative approach that induced ...remission in small series of patients with active UC. We investigated its safety and efficacy in a placebo-controlled randomized trial. Methods We performed a parallel study of patients with active UC without infectious diarrhea. Participants were examined by flexible sigmoidoscopy when the study began and then were randomly assigned to groups that received FMT (50 mL, via enema, from healthy anonymous donors; n = 38) or placebo (50 mL water enema; n = 37) once weekly for 6 weeks. Patients, clinicians, and investigators were blinded to the groups. The primary outcome was remission of UC, defined as a Mayo score ≤2 with an endoscopic Mayo score of 0, at week 7. Patients provided stool samples when the study began and during each week of FMT for microbiome analysis. The trial was stopped early for futility by the Data Monitoring and Safety Committee, but all patients already enrolled in the trial were allowed to complete the study. Results Seventy patients completed the trial (3 dropped out from the placebo group and 2 from the FMT group). Nine patients who received FMT (24%) and 2 who received placebo (5%) were in remission at 7 weeks (a statistically significant difference in risk of 17%; 95% confidence interval, 2%−33%). There was no significant difference in adverse events between groups. Seven of the 9 patients in remission after FMT received fecal material from a single donor. Three of the 4 patients with UC ≤1 year entered remission, compared with 6 of 34 of those with UC >1 year ( P = .04, Fisher’s exact test). Stool from patients receiving FMT had greater microbial diversity, compared with baseline, than that of patients given the placebo ( P = .02, Mann-Whitney U test). Conclusions FMT induces remission in a significantly greater percentage of patients with active UC than placebo, with no difference in adverse events. Fecal donor and time of UC appear to affect outcomes. ClinicalTrials.gov Number: NCT01545908.
BACKGROUND:
Fecal microbiota transplantation (FMT) is becoming popular treatment option for a variety of diseases, including ulcerative colitis (UC). Despite increasing evidence for its role as a ...therapeutic, currently available literature is limited in its scope to assess firsthand patient experiences. We explored perceptions, attitudes, and experiences of patients who chose to pursue FMT and patients who declined FMT in favor of conventional medications.
METHODS:
This study used a qualitative descriptive design, embedded within a larger randomized controlled trial (RCT) of adult patients diagnosed with UC enrolled in accessing efficacy of FMT (NCT02606032). Patients were invited to participate in face-to-face semi-structured interviews before and after treatment. Perceptions about FMT were compared to patients who were eligible to participate in the RCT but chose to pursue conventional medications. Interviews were audiotaped, transcribed, and analyzed using thematic analysis.
RESULTS:
We interviewed 9 patients who underwent FMT treatment and 8 patients who declined FMT treatment. The main themes across the two groups at baseline included: (i) knowledge of FMT, (ii) attitudes around FMT, and (iii) factors contributing to the decision to pursue FMT. Post-FMT, prominent themes included: (i) experiences with FMT, and (ii) perceived response to treatment. We uncovered a poor general understanding of FMT across both cohorts of patients, suggesting a need for improved patient education. Compared to FMT patients, non-FMT patients were less likely to have heard or researched FMT in the past due to feelings of “it just sounds weird”. Similar hesitations with FMT were felt across both groups, including fear of transmissible infections, cost of commitment to an experimental therapy, and inherent aversion to stool. Expectations of FMT varied between the two groups, with feelings of hope in the treatment and a sense of “last resort” driving patients to pursue FMT. In contrast, the non-FMT cohort felt a need to further research FMT and explore other treatment options before committing to FMT and were more likely to minimise their disease activity as “not at the severe end”. This demonstrates that FMT may be perceived as a “last ditch effort” for many patients. Despite initial aversion, the non-FMT patients demonstrated interest in learning more about FMT and expressed having felt more open to the possibility of pursuing FMT in the future. Those that underwent FMT viewed FMT as a natural treatment and were more eager to explore alternative medicine in comparison to the non-FMT cohort who expressed “I’m not really into the weird stuff”. Post-FMT, some patients expressed delight in the perceived change in their symptoms, voicing an improved quality of life, decreased bowel urgency, and less concerns with soiling accidents.
CONCLUSION(S):
We explored perceptions and experiences with FMT in UC patients who chose to pursue FMT to patients who declined FMT for conventional treatments. While many of the pre-FMT perceptions are comparable across the two groups, important motivating factors in favor of FMT appears to be a perception of naturality and a last resort option. These results suggest that with improved education, FMT may pose an acceptable and tolerable treatment options for patients with UC.
Abstract
Background
Fecal microbiota transplantation (FMT) is a promising experimental therapy for ulcerative colitis (UC), yet patient acceptance remains poorly understood.
Aims
The aim of this ...study was to explore perceptions and experiences of adult patients who received FMT for UC.
Methods
This study used a qualitative descriptive design with thematic content analysis. Patients who were approached for enrollment in a clinical trial (NCT02606032) were invited to participate in face-to-face semistructured interviews. Two groups were interviewed: those who chose to pursue FMT and those who declined FMT. Non-FMT patients were interviewed once; FMT patients were interviewed twice at pre- and post-treatment.
Results
Nine FMT patients (78% female, average age 46.7 years old) and eight non-FMT patients (50% female, average age 39.5 years old) were enrolled. Pretreatment themes included FMT as a natural therapy, external barriers to pursuing FMT, concerns with FMT and factors influencing the decision to pursue FMT. While both groups generally perceived FMT as a natural therapy, pre-FMT patients showed greater acceptance of alternative medicine. Both groups demonstrated poor understanding and similar initial concerns with product cleanliness. Pre-FMT patients were motivated to pursue FMT by feelings of last resort. Post-FMT themes included therapeutic impact of FMT and psychosocial impact of FMT. Post-FMT patients reported overall satisfaction and a unanimous preference for FMT over conventional medications.
Conclusion
This is the first study to assess adult patient perceptions and real-life experiences with FMT for the treatment of UC. By improving patient education, we may achieve greater acceptance of FMT.
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