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

Fecal Microbiota Transplantation for IBS | DecenTrialz