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NCT05776914 · ClinicalTrials.gov registry record · Phase 2

Fecal Microbiota Transplantation for IBS

A Phase 2 study of Irritable Bowel Syndrome and Diarrhea, sponsored by Madhusudan (Madhu) Grover, MBBS.

Recruiting
Registry status
Phase 2
Development phase
43
Enrollment target
1
Study location

NCT05776914: Recruiting Phase 2 study of Irritable Bowel Syndrome and Diarrhea, sponsored by Madhusudan (Madhu) Grover, MBBS.

NCT05776914 is a Phase 2 study of Irritable Bowel Syndrome and Diarrhea that is actively recruiting participants, run by Madhusudan (Madhu) Grover, MBBS. The registered enrollment target is 43 participants, below the 143-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05776914, a Phase 2 study of Irritable Bowel Syndrome and Diarrhea, is actively recruiting participants, sponsored by Madhusudan (Madhu) Grover, MBBS.

RECRUITING
Registry status
Phase 2
Development phase
43 participants
Enrollment target
1
Study location

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.

Primary Outcome

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.

Conditions Studied

Irritable Bowel Syndrome Diarrhea

Interventions

  • BIOLOGICAL Donor Fecal Microbiota Transplantation
  • BIOLOGICAL Autologous Fecal Microbiota Transplantation

Study Locations (1)

Minnesota

  • Mayo Clinic in Minnesota - Rochester

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2024-04-15
Est. Completion 2026-12
Phase Phase 2
Madhusudan (Madhu) Grover, MBBS

1 total trials

What NCT05776914 shows while recruiting

NCT05776914 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 143-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (70% lower).

The record links to 2 conditions, with Irritable Bowel Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Donor Fecal Microbiota Transplantation is the first listed.

NCT05776914 reports a single indexed study location in Minnesota.

Frequently Asked Questions

What is clinical trial NCT05776914 about?

NCT05776914 is a clinical study titled "Fecal Microbiota Transplantation for IBS". 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 a...

What is the current status of trial NCT05776914?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2024-04-15. Estimated completion is 2026-12.

What conditions does trial NCT05776914 study?

This clinical trial studies the following conditions: Irritable Bowel Syndrome, Diarrhea.

What interventions are being tested in trial NCT05776914?

The interventions under investigation include: Donor Fecal Microbiota Transplantation (BIOLOGICAL), Autologous Fecal Microbiota Transplantation (BIOLOGICAL).

Who is sponsoring clinical trial NCT05776914?

This trial is sponsored by Madhusudan (Madhu) Grover, MBBS, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05776914 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05776914's enrollment target sits among peer trials

43 36th of 47 higher than 12 of 47 other Irritable Bowel Syndrome trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Irritable Bowel Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05776914

Source: ClinicalTrials.gov NCT05776914, the US trial registry maintained by the National Library of Medicine. NCT05776914 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.