Recruiting
Phase 1

FMT

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT05664113

Conditions

Gastro-Intestinal Disorder

Eligibility Criteria

Sex: All

Age: 0 - 22

Healthy Volunteers: Not accepted

Interventions

Fecal microbiota transplant (FMT)

Study Details

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.

Conditions

Gastro-Intestinal Disorder

Study ID

NCT05664113

Start date

Jul 7, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 22

Healthy Volunteers: Not accepted

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:

  • Participant is at risk for aspiration pneumonia
  • History of anaphylactic allergy to foods that are not excluded from the stool donor diet
  • 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.

Study Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Stratum A

Diagnosed with GvHD

experimental: Stratum B

GI Dysfunction

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

Primary outcome measure

  • Proportion of participants with a serious adverse event occurring within 30 days following FMT [ Time Frame: 30 Days ]
  • Proportion of participants with a non-serious adverse event occurring within 30 days following FMT [ Time Frame: 30 Days ]
  • Proportion of participants expressing interest who meet eligibility [ Time Frame: 2 years ]
  • Proportion of participants recruited in the eligible population [ Time Frame: 2 years ]
  • Proportion of participants that drop up post-enrollment [ Time Frame: 3 years ]
  • Proportion of participants providing all protocol required stool samples [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-07-20.