Actively Recruiting
Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation (FMT) for Gastrointestinal Dysfunction in Children Following Hematopoietic Cell Transplant (HCT).
Led by St. Jude Children's Research Hospital · Updated on 2026-02-10
10
Participants Needed
1
Research Sites
181 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation (FMT) for Gastrointestinal Dysfunction in Children Following Hematopoietic Cell Transplant (HCT).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age less than 22 years old
- Received an allogeneic Hematopoietic Cell Transplant at least 30 days before enrollment
- Diagnosed with steroid-resistant gut graft-versus-host disease (GvHD), defined as gastrointestinal symptoms not improving within 5 days after steroid therapy at 1 mg/kg or more of prednisolone
- Diagnosed with steroid-dependent gut GvHD, defined as response to methylprednisolone 2 mg/kg/day but relapse when tapering steroids
- OR current or prolonged gastrointestinal dysfunction after HCT, with diarrhea or loose stools lasting 4 weeks or more plus at least one of the following: requiring nasogastric or gastrostomy tube feeds; requiring total parenteral nutrition or intravenous fluids for more than 4 weeks; diagnosis of gastroparesis documented by a GI specialist
- Willing and able to provide informed assent or consent
You will not qualify if you...
- Cytomegalovirus (CMV) or Epstein Barr Virus (EBV) IgG negative at consent
- Female participants who are pregnant or nursing
- History of previous fecal microbiota transplant (FMT)
- Intra-abdominal surgery within 4 weeks of enrollment
- At increased risk for peritonitis, including presence of intra-abdominal devices other than gastrostomy or gastrojejunostomy tubes, receiving peritoneal dialysis, or having ascites
- Concurrent abdominal radiation therapy
- Any acute or chronic illness or medication that the investigator believes increases risk from FMT or could affect study results
AI-Screening
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Trial Site Locations
Total: 1 location
1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
G
Gabriela Maron, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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