Fecal Microbiota Transplant (FMT) for Children with Gut Issues After Stem Cell Transplant
This study is looking at the safety and potential benefits of Fecal Microbiota Transplantation (FMT) for children up to 22 years old who have gastrointestinal (GI) problems after a stem cell transplant (Hematopoietic Cell Transplant or HCT). You might be able to join if you have steroid-resistant gut GvHD (Graft versus Host Disease, where donor cells attack your body) or other gut issues after your HCT. The FMT involves receiving microbiota preparation material either through a tube into your nose and stomach, or through a colonoscopy. Researchers will be watching closely for any serious or non-serious side effects within 30 days of the FMT. They also want to see how many interested people meet the study requirements.
- Study design
- This is an interventional study with a planned enrollment of 10 participants. It is not specified if it is randomized or blinded.
- What's involved
- Participants will receive Fecal Microbiota Transplantation (FMT) via naso-enteral tube and colonoscopy. A second FMT may be given at least 14 days after the first if symptoms haven't fully improved.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will monitor for adverse events for 30 days after FMT. They will also track how many people meet eligibility for up to 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation (FMT) for Gastrointestinal Dysfunction in Children Following Hematopoietic Cell Transplant (HCT).
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Gabriela Maron, MD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Proportion of participants with a serious adverse event occurring within 30 days following FMT30 Days
Serious adverse events will be a primary outcome measure for the following groups: * FMT for treating a GvHD of the gut following HCT * FMT for treating HCT induced gut dysfunction
- Proportion of participants with a non-serious adverse event occurring within 30 days following FMT30 Days
Non-serious adverse events will be a primary outcome measure for the following groups: * FMT for treating a GvHD of the gut following HCT * FMT for treating HCT induced gut dysfunction
- Proportion of participants expressing interest who meet eligibility2 years
Participant eligibility will be a primary outcome measure for the following groups: * FMT for treating a GvHD of the gut following HCT * FMT for treating HCT induced gut dysfunction
- Proportion of participants recruited in the eligible population2 years
Participant recruitment will be a primary outcome measure for the following groups: * FMT for treating a GvHD of the gut following HCT * FMT for treating HCT induced gut dysfunction
- Proportion of participants that drop up post-enrollment3 years
Participant retention will be a primary outcome measure for the following groups: * FMT for treating a GvHD of the gut following HCT * FMT for treating HCT induced gut dysfunction
- Proportion of participants providing all protocol required stool samples3 years
Stool specimens will be a primary outcome measure for the following groups: * FMT for treating a GvHD of the gut following HCT * FMT for treating HCT induced gut dysfunction