Fecal Microbiota Transplantation for IBS

NCT05776914 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 22-005385
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome; Diarrhea

Keywords

Post-infection irritable bowel syndrome with diarrheal; Post-infection irritable bowel syndrome with mixed symptoms

Outcome Measures

Primary Outcomes (1)

• Percentage of responders

  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.

  12 weeks

Secondary Outcomes (5)

• Change in level of fecal proteolytic activity

  Baseline, 12 weeks

• Changes in in vivo excretion of 2-24 hr lactulose excretion

  Baseline, 12 weeks

• Number of weekly responders

  12 weeks

• Global Adequate Relief Questionnaire

  12 weeks

• Alistipes putredinis proportion post-FMT

  12 weeks

Study Arms (2)

Donor Fecal Microbiota Transplantation Group

EXPERIMENTAL

Subjects will receive a fecal microbiota transplantation (FMT) using stool from a donor

Biological: Donor Fecal Microbiota Transplantation

Autologous Fecal Microbiota Transplantation Group

PLACEBO COMPARATOR

Subjects will receive a fecal microbiota transplantation (FMT) using their own stool

Biological: Autologous Fecal Microbiota Transplantation

Interventions

Donor Fecal Microbiota Transplantation BIOLOGICAL

Single fecal microbiota transplantation using 50 gm of freeze-thawed donor stool

Donor Fecal Microbiota Transplantation Group

Autologous Fecal Microbiota Transplantation BIOLOGICAL

Single fecal microbiota transplantation using 50 gm of stool collected from the same individual

Autologous Fecal Microbiota Transplantation Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Madhusudan (Madhu) Grover, MBBS: lead

Study Sites (1)

Mayo Clinic in Minnesota

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Irritable Bowel Syndrome; Diarrhea

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Madhusudan Grover, MBBS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonah Pedelty, MS

CONTACT

507-538-7774; pedelty.jonah@mayo.edu

Margaret Breen-Lyles

CONTACT

507-422-5759; breen-lyles.margaret@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Regulatory Sponsor and Principal Investigator

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 20, 2023
• Study Start: April 15, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)