Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation (FMT) for Gastrointestinal Dysfunction in Children Following Hematopoietic Cell Transplant (HCT).
Recruiting now · Phase 1
Conditions studied: Gastro-Intestinal Disorder
In brief
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 facts
- Study ID
- NCT05664113
- Run by
- St. Jude Children's Research Hospital
- People needed
- 10
- Starts
- 2025-07-07
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-07-20
Who can join
Age: any, up to 22. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age < 22 years old.
- Received an allogeneic HCT greater than or equal to 30 days prior to enrollment
- Diagnosed with one of the following conditions:
- Steroid-resistant gut a GvHD (defined as GI symptoms that do not improve within 5 days after initial steroid therapy, >/= 1mg/kg of prednisolone) OR
- Steroid-dependent gut a GvHD (defined as the presence of a response to methylprednisolone 2 mg/kg/day but relapsing when an attempt was made to taper steroid treatment).
- OR
- Current or prolonged GI dysfunction following HCT, defined as having diarrhea or loose stools >/= 4 weeks with at least one of the following:
- Requiring NG or G-tube feeds
- Requiring TPN or IVF for more than 4 weeks
- Diagnosis of gastroparesis by GI specialist documented in the medical record
- Willing and able to provide informed assent/consent
You may not qualify if…
- Participant is at risk for aspiration pneumonia
- History of anaphylactic allergy to foods that are not excluded from the stool donor diet
- Female participant who is pregnant or nursing
- History of previous FMT
- Intra-abdominal surgery within 4 weeks of enrollment
- At increased risk for peritonitis: presence of intra-abdominal devices (G-or GJ-tubes are acceptable), receiving peritoneal dialysis, or ascites
- Concurrent abdominal radiation therapy
- Any acute or chronic illness/condition as well as medication that in the opinion of the investigator puts the subject at greater risk from FMT or may confound the study results.
Where it is running
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.