NCT05776914 Fecal Microbiota Transplantation for IBS
| NCT ID | NCT05776914 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Madhusudan (Madhu) Grover, MBBS |
| Condition | Irritable Bowel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 43 participants |
| Start Date | 2024-04-15 |
| Primary Completion | 2027-06-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 43 participants in total. It began in 2024-04-15 with a primary completion date of 2027-06-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Madhusudan Grover, MBBS
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT05776914 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Irritable Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05776914 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05776914 currently recruiting?
Yes, NCT05776914 is actively recruiting participants. Contact the research team at pedelty.jonah@mayo.edu for enrollment information.
Where is the NCT05776914 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT05776914 clinical trial?
NCT05776914 is sponsored by Madhusudan (Madhu) Grover, MBBS. The principal investigator is Madhusudan Grover, MBBS at Mayo Clinic. The trial plans to enroll 43 participants.