Actively Recruiting

Phase 2
Age: 18Years - 70Years
FEMALE
NCT05776914

Fecal Microbiota Transplantation for IBS

Led by Madhusudan (Madhu) Grover, MBBS · Updated on 2026-05-08

43

Participants Needed

1

Research Sites

166 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Fecal Microbiota Transplantation for IBS

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • IBS defined by Rome IV criteria
  • Non IBS-C type
  • Moderate to severe symptoms defined by IBS-SSS65175
  • Able to safely undergo and consent to colonoscopy
Not Eligible

You will not qualify if you...

  • Immune deficiency or treatment with immunosuppressive medications
  • Severe bowel or medical disease precluding bowel prep
  • Severe bowel or medical disease precluding colonoscopy with conscious sedation
  • Active cancer
  • Pregnant or lactating
  • Abdominal surgery except specified types (e.g., splenectomy, partial hepatectomy, laparoscopy, appendectomy)
  • Severe psychiatric disorder or diagnosed alcohol or drug abuse disorder
  • New probiotics or treatment with antibiotics, NSAIDs within 4 weeks prior to study entry
  • Use of treatments known to affect colonic motility except loperamide
  • Diagnosed history of bleeding disorder
  • Organic GI diseases such as IBD, celiac disease, microscopic colitis
  • Chronic kidney or liver disease
  • Absolute neutrophil count (ANC) less than 500 IU/ml

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Mayo Clinic in Minnesota

Rochester, Minnesota, United States, 55905

Actively Recruiting

Loading map...

Research Team

J

Jonah Pedelty, MS

CONTACT

M

Margaret Breen-Lyles

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Fecal Microbiota Transplantation for IBS | DecenTrialz