Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation (FMT) for Gastrointestinal Dysfunction in Children Following Hematopoietic Cell Transplant (HCT).
2 other identifiers
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2025
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2022
CompletedFirst Posted
Study publicly available on registry
December 23, 2022
CompletedStudy Start
First participant enrolled
July 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
February 10, 2026
February 1, 2026
1.5 years
December 15, 2022
February 6, 2026
Conditions
Outcome Measures
Primary Outcomes (6)
Proportion of participants with a serious adverse event occurring within 30 days following FMT
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
30 Days
Proportion of participants with a non-serious adverse event occurring within 30 days following FMT
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
30 Days
Proportion of patients expressing interest who meet eligibility
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
2 years
Proportion of patients recruited in the eligible population
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
2 years
Proportion of participants that drop up post-enrollment
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
3 years
Proportion of participants providing all protocol required stool samples
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
3 years
Secondary Outcomes (2)
Proportion of participants with a complete response or a partial response
180 days
Percentage of participants who reduce or discontinue steroids at the end of the study
1 year
Study Arms (2)
Stratum A
EXPERIMENTALDiagnosed with GvHD
Stratum B
EXPERIMENTALGI Dysfunction
Interventions
FMT Lower Delivery Microbiota Preparation, Dose: 250 mL of Microbiota Preparation Material and Route of administration: colonoscopy FMT Upper Delivery Microbiota Preparation, Dose: 60 mL of Microbiota Preparation Material and Route of administration: Naso-enteral tube
Eligibility Criteria
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).
- 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:
- Cytomegalovirus (CMV) or Epstein Barr Virus (EBV) IgG negative at the time of consent
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriela Maron, MD
St. Jude Children's Research Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2022
First Posted
December 23, 2022
Study Start
July 7, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2028
Last Updated
February 10, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be made available at the time of article publication.
- Access Criteria
- Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.
Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.