RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-12

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05664113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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). 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	* 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.

Inclusion Criteria

Exclusion 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).
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

* 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.

Contacts and Locations

Study Contact

Gabriela Maron, MD

CONTACT

866-278-5833

referrainfo@stjude.org

Principal Investigator

Gabriela Maron, MD

PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Study Locations (Sites)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105

United States

Collaborators and Investigators

Sponsor: St. Jude Children's Research Hospital

Gabriela Maron, MD, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-12

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-03-12

Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

Gastro-Intestinal Disorder