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

NCT05664113 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-05-19

No results posted yet for this 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.

Conditions

  • Gastro-Intestinal Disorder

Interventions

DRUG

Fecal microbiota transplant (FMT)

FMT Lower Delivery Microbiota Preparation, Dose: 250 mL of Microbiota Preparation Material and Route of administration: colonoscopy FMT Upper Delivery Microbiota Preparation, Dose: 60 mL of Microbiota Preparation Material and Route of administration: Naso-enteral tube

Sponsors & Collaborators

Principal Investigators

  • Gabriela Maron, MD · St. Jude Children's Research Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-07
Primary Completion
2026-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05664113 on ClinicalTrials.gov