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

NCT ID: NCT05664113

Last Updated: 2026-02-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-07
• Study Completion Date: 2028-12-31

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.

Detailed Description

Participants will be eligible to receive an FMT on or after Day +30 post-HCT. FMT will be performed using FMP material obtained from OpenBiome. 60 mL of FMP will be administered via NJ tube and 250 mL via colonoscopy. A second FMT may be performed at least 14 days after the initial FMT in GI clinical symptoms have partially improved or have not changed. The second FMT will be administered using the same procedure as in the initial FMT

Conditions

Gastro-Intestinal Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stratum A

Diagnosed with GvHD

Group Type: EXPERIMENTAL

Fecal microbiota transplant (FMT)

Intervention Type: DRUG

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

Stratum B

GI Dysfunction

Group Type: EXPERIMENTAL

Fecal microbiota transplant (FMT)

Intervention Type: DRUG

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

Interventions

Fecal microbiota transplant (FMT)

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

Intervention Type: DRUG

Other Intervention Names

FMT

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

• 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.

• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Jude Children's Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabriela Maron, MD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Gabriela Maron, MD

Role: CONTACT

referrainfo@stjude.org

866-278-5833

Facility Contacts

Gabriela Maron, MD

Role: primary

referralinfo@stjude.org

866-278-5833

Related Links

http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

NCI-2024-02553

Identifier Type: OTHER

Identifier Source: secondary_id

NEWGUT

Identifier Type: -

Identifier Source: org_study_id