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RECRUITING
NCT05664113
PHASE1

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

Sponsor: St. Jude Children's Research Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

Any - 22 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-07-07

Completion Date

2028-12-31

Last Updated

2026-02-10

Healthy Volunteers

No

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

Locations (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, United States