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Microbiota Restoration

Fecal Microbiota Transplant for Irritable Bowel Syndrome

Phase 2
Recruiting
Led By Madhusudan Grover, MBBS
Research Sponsored by Madhusudan (Madhu) Grover, MBBS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks

Summary

This trial studies the safety and effectiveness of FMT using donor stool with low protein breakdown and Alistipes putredinis bacteria to treat PI-IBS and high protein breakdown.

Who is the study for?
This trial is for individuals with post-infection irritable bowel syndrome (PI-IBS) who experience moderate to severe symptoms. They must be able to undergo a colonoscopy and not have constipation-dominant IBS. People with recent abdominal surgery, bleeding disorders, low neutrophil count, active cancer, certain GI diseases, or those pregnant or on immune-suppressing drugs cannot participate.
What is being tested?
The study tests the effectiveness of fecal microbiota transplantation (FMT). Participants will receive stool from a donor with specific bacteria thought to help PI-IBS symptoms versus their own stool. The goal is to see if this can reduce protein breakdown in the gut linked to IBS.
What are the potential side effects?
Potential side effects may include discomfort at the transplant site, changes in bowel habits, abdominal pain or bloating. There's also a risk of infection transmission from donor material despite screening.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of responders
Secondary study objectives
Alistipes putredinis proportion post-FMT
Change in level of fecal proteolytic activity
Changes in in vivo excretion of 2-24 hr lactulose excretion
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Donor Fecal Microbiota Transplantation GroupExperimental Treatment1 Intervention
Subjects will receive a fecal microbiota transplantation (FMT) using stool from a donor
Group II: Autologous Fecal Microbiota Transplantation GroupPlacebo Group1 Intervention
Subjects will receive a fecal microbiota transplantation (FMT) using their own stool

Find a Location

Who is running the clinical trial?

Madhusudan (Madhu) Grover, MBBSLead Sponsor
Madhusudan Grover, MBBSPrincipal InvestigatorMayo Clinic
6 Previous Clinical Trials
391 Total Patients Enrolled
3 Trials studying Irritable Bowel Syndrome
309 Patients Enrolled for Irritable Bowel Syndrome

Media Library

Autologous Fecal Microbiota Transplantation (Microbiota Restoration) Clinical Trial Eligibility Overview. Trial Name: NCT05776914 — Phase 2
Irritable Bowel Syndrome Research Study Groups: Donor Fecal Microbiota Transplantation Group, Autologous Fecal Microbiota Transplantation Group
Irritable Bowel Syndrome Clinical Trial 2023: Autologous Fecal Microbiota Transplantation Highlights & Side Effects. Trial Name: NCT05776914 — Phase 2
Autologous Fecal Microbiota Transplantation (Microbiota Restoration) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05776914 — Phase 2
~24 spots leftby Sep 2025
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