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Fecal Microbiota Transplantation Induces Remission in Patients with Active Ulcerative Colitis in a Randomized, Controlled Trial
 
Anna Maria S Views: 2,289
Published: 6 years ago
 

Fecal Microbiota Transplantation Induces Remission in Patients with Active Ulcerative Colitis in a Randomized, Controlled Trial


Fecal Microbiota Transplantation Induces Remission in Patients with Active Ulcerative Colitis in a Randomized, Controlled Trial

Paul Moayyedi

Published Online: April 06, 2015

Publication stage: In Press Accepted Manuscript


http://www.gastrojournal.org/article/S0016-5085(15)00451-5/abstract



Abstract

Background & Aims

Ulcerative colitis (UC) is difficult to treat and standard therapy does not always induce remission. Fecal microbial transplantation (FMT) is an alternative approach that induced remission in 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 to 6/34 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.



Keywords:
IBD, treatment, microbe, colon
 

 
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