Fecal Microbiota Transplantation for IBS

Phase 2

Recruiting

• Conditions: Diarrhea; Irritable Bowel Syndrome
• Interventions: Biological: Donor Fecal Microbiota Transplantation; Biological: Autologous Fecal Microbiota Transplantation

• Registration Number: NCT05776914
• Lead Sponsor: Madhusudan (Madhu) Grover, MBBS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-17
• Study First Posted: 2023-03-20
• Study Start: 2024-04-15
• Status Verified: 2024-05
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 43

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Donor Fecal Microbiota Transplantation Group	Donor Fecal Microbiota Transplantation	Subjects will receive a fecal microbiota transplantation (FMT) using stool from a donor
Autologous Fecal Microbiota Transplantation Group	Autologous Fecal Microbiota Transplantation	Subjects will receive a fecal microbiota transplantation (FMT) using their own stool

Primary Outcome Measures

Name	Time	Method
Percentage of responders	12 weeks	Number of subjects receiving the donor fecal microbiota transplantation identified as a responder defined as a decrease of ≥50 points in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) from baseline.; The Irritable Bowel Syndrome Symptom Severity Score scale has a possible range of scores from 0-500. Mild cases are classified as a score of 75-175, moderate cases are classified as a score of 175-300, and severe cases are classified as a score of \>300.

Secondary Outcome Measures

Name	Time	Method
Changes in in vivo excretion of 2-24 hr lactulose excretion	Baseline, 12 weeks	Measured by permeability testing
Change in level of fecal proteolytic activity	Baseline, 12 weeks	The level of fecal proteolytic activity will be measured at baseline and again at 12 weeks. The proteolytic activity is measured using a standardized FITC Casein assay that relies on the activity of proteases in the sample to digest casein protein.
Global Adequate Relief Questionnaire	12 weeks	Number of subjects to report adequate relief of IBS symptoms, measured by answering yes to question "In the past 7 days have you had adequate relief of your IBS symptoms?"
Number of weekly responders	12 weeks	Number of subjects to meet responder criteria of ≥30% decrease in average of worst abdominal pain in past 24 hours plus ≥50% decrease in the number of days per week with at least one stool that has a consistency of Type 6 or 7 (compared with baseline)
Alistipes putredinis proportion post-FMT	12 weeks	Number of subject to have the bacteria Alistipes putredinis in stool sample after fecal microbiota transplantation (FMT)

Trial Locations

Locations (1)

Mayo Clinic in Minnesota; 🇺🇸 Rochester, Minnesota, United States