Study of Fecal Microbiota Transplantation Using Low Proteolytic Activity Donor Stool to Treat Irritable Bowel Syndrome in Women Aged 18 to 70

What this Trial Is About

Researchers are evaluating the effectiveness and safety of fecal microbiota transplantation FMT for patients with irritable bowel syndrome IBS who have high proteolytic activity. This study focuses on using stool from donors with low proteolytic activity containing the bacteria Alistipes putredinis. Proteolytic activity refers to the breakdown of proteins into smaller components, and the trial aims to see if this approach can impact IBS symptoms. This is a phase 2 randomized, double-blind study. Participants will receive a single FMT using 50 grams of freeze-thawed stool either from a donor with low proteolytic activity experimental group or from their own stool placebo comparator group. The treatment is administered via colonoscopy, and only one transplantation is given. The study compares donor stool transplantation to autologous transplantation to assess differences in outcomes. During the 12-week study period, participants will be monitored for responses to treatment, including changes in fecal proteolytic activity and symptom relief using questionnaires. Assessments include measuring the proportion of the bacteria Alistipes putredinis post-FMT and lactulose excretion levels. Safety is also monitored, and the primary outcome is the percentage of responders at 12 weeks. The trial involves women aged 18 to 70 with moderate to severe IBS symptoms, with follow-up evaluations at baseline and 12 weeks.

Fecal Microbiota Transplantation for IBS