Status:
RECRUITING
Fecal Microbiota Transplantation for IBS
Lead Sponsor:
Madhusudan (Madhu) Grover, MBBS
Conditions:
Irritable Bowel Syndrome
Diarrhea
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
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 put...
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
Key Trial Info
Start Date :
April 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT05776914
Start Date
April 15 2024
End Date
December 1 2026
Last Update
October 24 2025
Active Locations (1)
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1
Mayo Clinic in Minnesota
Rochester, Minnesota, United States, 55905