NCT05664113 Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation (FMT) for Gastrointestinal Dysfunction in Children Following Hematopoietic Cell Transplant (HCT).
| NCT ID | NCT05664113 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | St. Jude Children's Research Hospital |
| Condition | Gastro-Intestinal Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-07-07 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-07-07 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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: 1. 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 2. 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 3. Current or prolonged GI dysfunction following HCT, defined as having diarrhea or loose stools \>/= 4 weeks with at least one of the following: 1. Requiring NG or G-tube feeds 2. Requiring TPN or IVF for more than 4 weeks 3. Diagnosis of gastroparesis by GI specialist documented in the medical record * Willing and able to provide informed assent/consent Exclusion Criteria: * 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.
Contact & Investigator
Gabriela Maron, MD
PRINCIPAL INVESTIGATOR
St. Jude Children's Research Hospital
Frequently Asked Questions
Who can join the NCT05664113 clinical trial?
This trial is open to participants of all sexes, up to 22 Years, studying Gastro-Intestinal Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05664113 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05664113 currently recruiting?
Yes, NCT05664113 is actively recruiting participants. Contact the research team at referrainfo@stjude.org for enrollment information.
Where is the NCT05664113 trial being conducted?
This trial is being conducted at Memphis, United States.
Who is sponsoring the NCT05664113 clinical trial?
NCT05664113 is sponsored by St. Jude Children's Research Hospital. The principal investigator is Gabriela Maron, MD at St. Jude Children's Research Hospital. The trial plans to enroll 10 participants.