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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
Able to safely undergo and consent to colonoscopy
Moderate to severe symptoms defined by IBS-SSS≥175
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can safely have and agree to a colonoscopy.
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My IBS symptoms are moderate to severe.
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I have been diagnosed with post-infectious IBS caused by Campylobacter.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of responders
Secondary outcome measures
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric individuals eligible for enrollment in this research initiative?

"This medical investigation is attempting to enroll participants aged 18 and over, yet under the age of 70."

Answered by AI

To whom is this clinical experiment open for enrollment?

"Eligibility to join this clinical trial is contingent upon having a diagnosis of irritable bowel syndrome and being between 18-70 years old. Approximately 43 participants are expected to be enrolled in the study."

Answered by AI

Does this experiment have any open slots for enrolment?

"The current listing on clinicaltrials.gov confirms there is no longer a search for participants in this trial, which began recruiting patients on March 1st 2023 and had its last update 17 days later. Nevertheless, 1523 other trials are actively admitting new members right now."

Answered by AI

Are there any risks associated with Donor Fecal Microbiota Transplantation Group for those receiving the treatment?

"Donor Fecal Microbiota Transplantation Group is estimated to have a safety score of 2. This assessment was based on the fact that this clinical trial is in Phase 2, showcasing some data backing its security but no evidence confirming its efficacy."

Answered by AI
~29 spots leftby Sep 2025