RecruitingPhase 1

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

United States10 participantsStarted 2025-07-07

Plain-language 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.

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of participants with a serious adverse event occurring within 30 days following FMT

Timeframe: 30 Days

Proportion of participants with a non-serious adverse event occurring within 30 days following FMT

Timeframe: 30 Days

Proportion of patients expressing interest who meet eligibility

Timeframe: 2 years

Proportion of patients recruited in the eligible population

Timeframe: 2 years

Proportion of participants that drop up post-enrollment

Timeframe: 3 years

Proportion of participants providing all protocol required stool samples

Timeframe: 3 years

Trial details

NCT IDNCT05664113

SponsorSt. Jude Children's Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Gabriela Maron, MD

888-226-4343 referrainfo@stjude.org

View on ClinicalTrials.gov More Gastro-Intestinal Disorder trials

Plain-language summary

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).
. 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

What they're measuring

Proportion of participants with a serious adverse event occurring within 30 days following FMT

Timeframe: 30 Days

Proportion of participants with a non-serious adverse event occurring within 30 days following FMT

Timeframe: 30 Days

Proportion of patients expressing interest who meet eligibility

Timeframe: 2 years

Proportion of patients recruited in the eligible population

Timeframe: 2 years

Proportion of participants that drop up post-enrollment

Timeframe: 3 years

Proportion of participants providing all protocol required stool samples

Timeframe: 3 years