drugset
drugset / Trial / NCT05664113

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

NCT05664113 ↗

Phase 1 Recruiting 10 enrolled St. Jude Children's Research Hospital
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-07-07
Primary completion
2026-12-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Fecal Microbiota Transplant (FMT) Unknown 60 ml Other
Subject Fecal Microbiota Transplant (FMT) Unknown 250 ml Other

Indications

digestive system disorder