Fecal microbiota transplantation for treating irritable bowel syndrome
Efficacy and Safety of Proteolytic Activity-Guided Fecal Microbiota Transplantation for Irritable Bowel Syndrome (PRAGMAT Trial)
This study is testing if using stool from a healthy donor can help people with irritable bowel syndrome feel better by restoring a healthy balance of gut bacteria.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 43 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05776914 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy and safety of fecal microbiota transplantation (FMT) using stool from a donor with low proteolytic activity, specifically targeting patients with irritable bowel syndrome (IBS) characterized by high proteolytic activity. Participants will undergo either donor or autologous FMT to assess improvements in their IBS symptoms. The study focuses on individuals with moderate to severe symptoms as defined by established criteria. The approach seeks to restore a healthy gut microbiome to alleviate IBS symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with moderate to severe irritable bowel syndrome who meet specific inclusion criteria.
Not a fit: Patients with severe bowel or medical diseases, immune deficiencies, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from irritable bowel syndrome.
How similar studies have performed: Other studies have shown promising results with fecal microbiota transplantation for gastrointestinal disorders, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria * Immune deficiency or treatment with immunosuppressive medications * Severe bowel or medical disease precluding administration of bowel prep * Severe bowel or medical disease precluding colonoscopy with conscious sedation * Active cancer * Pregnant or lactating * 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) * Severe psychiatric disorder (HADS-A or D\>16), or diagnosed alcohol or drug abuse disorder * New probiotics or treatment with antibiotics, NSAIDs (within 4 wks prior to study entry) * Use of treatments known to affect colonic motility (with exception of loperamide) * 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Minnesota — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Madhusudan Grover, MBBS — Mayo Clinic
- Study coordinator: Jonah Pedelty, MS
- Email: pedelty.jonah@mayo.edu
- Phone: 507-538-7774
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.