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NCT05664113 · ClinicalTrials.gov registry record · Phase 1

Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation (FMT) for Gastrointestinal Dysfunction in Children Following Hematopoietic Cell Transplant (HCT).

A Phase 1 study of Gastro-Intestinal Disorder, sponsored by St. Jude Children's Research Hospital.

Recruiting
Registry status
Phase 1
Development phase
10
Enrollment target
1
Study location

NCT05664113: Recruiting Phase 1 study of Gastro-Intestinal Disorder, sponsored by St. Jude Children's Research Hospital.

NCT05664113 is a Phase 1 study of Gastro-Intestinal Disorder that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 10 participants, below the 183-participant average among 7 other Gastro-Intestinal Disorder trials with a reported enrollment target (95% 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

NCT05664113, a Phase 1 study of Gastro-Intestinal Disorder, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.

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

Study Summary

The study participant is being asked to take part in this clinical trial, a type of research study, because the participant has Gastrointestinal (GI) symptoms following a Hematopoietic Cell Transplant (HCT). Primary Objective * To determine the safety and feasibility of FMT for treating a GvHD of the gut following HCT. * To determine the safety and feasibility of FMT for treating HCT induced gut dysfunction. Secondary Objectives * To assess the potential efficacy of FMT for treating a GvHD of the gut following HCT. * To assess the potential efficacy of FMT for treating HCT induced gut dysfunction.

Primary Outcome

Serious adverse events will be a primary outcome measure for the following groups: * FMT for treating a GvHD of the gut following HCT * FMT for treating HCT induced gut dysfunction

Conditions Studied

Interventions

  • DRUG Fecal microbiota transplant (FMT)

Study Locations (1)

Tennessee

  • St. Jude Children's Research Hospital - Memphis

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2025-07-07
Est. Completion 2028-12-31
Phase Phase 1

What NCT05664113 shows while recruiting

NCT05664113 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 183-participant average among 7 other Gastro-Intestinal Disorder trials with a reported enrollment target (95% lower).

The record links to 1 condition, with Gastro-Intestinal Disorder appearing as the primary indexed condition, and to 1 intervention - of which Fecal microbiota transplant (FMT) is the first listed.

NCT05664113 reports a single indexed study location in Tennessee.

Frequently Asked Questions

What is clinical trial NCT05664113 about?

NCT05664113 is a clinical study titled "Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation (FMT) for Gastrointestinal Dysfunction in Children Following Hematopoietic Cell Transplant (HCT).". The study participant is being asked to take part in this clinical trial, a type of research study, because the participant has Gastrointestinal (GI) symptoms following a Hematopoietic Cell Transplant (HCT). Primary Objective * To determine the safety and feasibility of FMT for treating a GvHD of ...

What is the current status of trial NCT05664113?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2025-07-07. Estimated completion is 2028-12-31.

What conditions does trial NCT05664113 study?

This clinical trial studies the following conditions: Gastro-Intestinal Disorder.

What interventions are being tested in trial NCT05664113?

The interventions under investigation include: Fecal microbiota transplant (FMT) (DRUG).

Who is sponsoring clinical trial NCT05664113?

This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05664113 being conducted?

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

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Source: ClinicalTrials.gov NCT05664113, the US trial registry maintained by the National Library of Medicine. NCT05664113 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.