Fecal Microbiota Transplantation for IBS
Key facts
- Where
- Rochester, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT05776914, who can take part
Where in United States
- Mayo Clinic in MinnesotaRochester, United StatesContact: Jonah Pedelty, MSTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Madhusudan (Madhu) Grover, MBBS
- Trial code
- NCT05776914
- Record updated
- 8 May 2026
- Original description
The purpose of this study is to learn the efficacy and safety of fecal microbiota transplantation (FMT) using stool from a donor with low proteolytic activity and containing the bacteria Alistipes putredinis in patients with irritable bowel syndrome (IBS) and high proteolytic activity. Proteolytic activity is the breakdown of proteins into smaller polypeptides or amino acids.Read full original descriptionShow less
Efficacy and Safety of Proteolytic Activity-Guided Fecal Microbiota Transplantation for Irritable Bowel Syndrome (PRAGMAT Trial)
The purpose of this study is to learn the efficacy and safety of fecal microbiota transplantation (FMT) using stool from a donor with low proteolytic activity and containing the bacteria Alistipes putredinis in patients with irritable bowel syndrome (IBS) and high proteolytic activity. Proteolytic activity is the breakdown of proteins into smaller polypeptides or amino acids.
Inclusion: IBS defined by Rome IV criteria; Non IBS-C; Moderate to severe symptoms defined by IBS-SSS≥175; Able to safely undergo and consent to colonoscopy.
Exclusion: Immune deficiency or treatment with immunosuppressive medications; Abdominal surgery (exception of splenectomy, partial hepatectomy, partial/unilateral nephrectomy, laparoscopy, pelvic floor repair, mesh, liposuction, fundoplication, tubal ligation, gastric sleeve, oophorectomy, hernia, appendectomy, cholecystectomy, caesarean section and hysterectomy); New probiotics or treatment with antibiotics, NSAIDs (within 4 wks prior to study entry); Severe bowel or medical disease precluding administration of bowel prep; Severe bowel or medical disease precluding colonoscopy with conscious sedation; Active cancer; Severe psychiatric disorder (HADS-A or D>16), or diagnosed alcohol or drug abuse disorder; Diagnosed h/o bleeding disorder; Organic GI diseases (IBD, celiac disease, microscopic colitis); Chronic kidney or liver disease; Absolute neutrophil count (ANC) <500 IU/ml; Pregnant or lactating; Use of treatments known to affect colonic motility (with exception of loperamide).