Actively Recruiting
Efficacy and Safety of Proteolytic Activity-Guided Fecal Microbiota Transplantation for Irritable Bowel Syndrome (PRAGMAT Trial)
Led by Madhusudan (Madhu) Grover, MBBS · Updated on 2026-05-08
43
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
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.
CONDITIONS
Brief Title
Fecal Microbiota Transplantation for IBS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- IBS defined by Rome IV criteria
- Non IBS-constipation type
- Moderate to severe symptoms with IBS-SSS score of 175 or higher
- Able to safely undergo and consent to colonoscopy
You will not qualify if you...
- Immune deficiency or use of immunosuppressive medications
- Severe bowel or medical disease preventing bowel preparation
- Severe bowel or medical disease preventing colonoscopy with conscious sedation
- Active cancer
- Pregnant or lactating
- Abdominal surgery except specific listed procedures
- Severe psychiatric disorder or diagnosed alcohol or drug abuse
- Use of new probiotics, antibiotics, or NSAIDs within 4 weeks before study
- Use of treatments affecting colonic motility except loperamide
- Diagnosed bleeding disorder
- Organic gastrointestinal diseases such as IBD, celiac disease, microscopic colitis
- Chronic kidney or liver disease
- Absolute neutrophil count below 500 IU/ml
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive a single fecal microbiota transplantation using either donor stool or their own stool.
1 treatment visit and follow-up assessments over 12 weeks
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Minnesota
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
J
Jonah Pedelty, MS
M
Margaret Breen-Lyles
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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