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Fecal Microbiota Transplantation for Irritable Bowel Syndrome

This study is investigating a treatment for Irritable Bowel Syndrome (IBS) with diarrhea. It's looking at two types of Fecal Microbiota Transplantation (FMT): one uses stool from a healthy donor (Donor Fecal Microbiota Transplantation) and the other uses your own stool (Autologous Fecal Microbiota Transplantation). The goal is to see how safe and effective these treatments are for people with IBS who have high proteolytic activity (a process where proteins are broken down). Researchers are particularly interested in donor stool with low proteolytic activity and containing a specific bacteria called Alistipes putredinis. You may be eligible if you are a woman between 18 and 70 years old, have moderate to severe IBS (not IBS-C), and can safely have a colonoscopy. The study will measure how many people respond to the treatment after 12 weeks. The current status of this study is unclear.

Study design
This interventional study plans to enroll 43 participants. It compares Donor Fecal Microbiota Transplantation to Autologous Fecal Microbiota Transplantation.
What's involved
You would undergo a colonoscopy and receive a single 50 gm fecal microbiota transplant. You would also need to meet specific eligibility criteria, including having moderate to severe IBS.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 12 weeks after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05776914

Fecal Microbiota Transplantation for IBS

Recruiting
PHASE2Ages 18–70InterventionalTreatment
Madhusudan (Madhu) Grover, MBBS
~43 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:Donor Fecal Microbiota TransplantationAutologous Fecal Microbiota Transplantation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of responders
Measured over 12 weeks

Conditions

Irritable Bowel Syndrome
Diarrhea

Explore related trials

Irritable Bowel SyndromePost-infection Irritable Bowel SyndromeProteolytic activity

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Madhusudan Grover, MBBS · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Jonah Pedelty, MS
[email protected]
507-538-7774
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Percentage of responders12 weeks

    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.