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

• Status: Not yet recruiting
• Trial end date: 2027-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Jude Children's Research Hospital

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.