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

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT05664113
Phase
PHASE1
Status
Recruiting
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Conditions

  • Gastro-Intestinal Disorder

Eligibility Criteria

Sex
ALL
Age
N/A - 22 Years
Healthy Volunteers
Not accepted

Interventions

  • Fecal microbiota transplant (FMT) — DRUG
    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

Study Details

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 Dates

Start date
Jul 7, 2025
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Stratum A
    Diagnosed with GvHD
  • Experimental: Stratum B
    GI Dysfunction

Primary Outcome Measure

Proportion of participants with a serious adverse event occurring within 30 days following FMT [ Time Frame: 30 Days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105
Gabriela Maron, MD
[email protected]
888-226-4343

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By research site
St. Jude Children's Research Hospital· Memphis, TN

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