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Fecal Microbiota Transplantation for IBS

NCT05776914 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-05-08

No results posted yet for this study

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

Interventions

BIOLOGICAL

Donor Fecal Microbiota Transplantation

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

BIOLOGICAL

Autologous Fecal Microbiota Transplantation

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

Sponsors & Collaborators

  • Madhusudan (Madhu) Grover, MBBS

    lead OTHER

Principal Investigators

  • Madhusudan Grover, MBBS · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2027-06-26
Completion
2027-06-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05776914 on ClinicalTrials.gov