RecruitingPhase 1NCT05664113

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

Enrollment

10 participants

Start Date

Jul 7, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether fecal microbiota transplantation (FMT) — transferring healthy gut bacteria from a donor — can safely help children who have persistent gut problems after receiving a bone marrow (stem cell) transplant for a blood disorder or cancer. These gut problems include a condition called graft-versus-host disease (GvHD) and prolonged diarrhea. **You may be eligible if...** - You are under 22 years old - You received an allogeneic (donor) bone marrow or stem cell transplant at least 30 days ago - You have gut graft-versus-host disease (GvHD) that has not responded well to steroids, or you have had ongoing gut problems (diarrhea, feeding tube dependency, or inability to eat) for at least 4 weeks after your transplant **You may NOT be eligible if...** - You tested negative for CMV or EBV antibodies (a donor compatibility issue) - You are pregnant or nursing - You have had a previous FMT - You have had abdominal surgery within the past 4 weeks - You have conditions that increase the risk of infection in the abdomen (such as ascites or peritoneal dialysis) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFecal 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

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NCT05664113


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