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Recruiting

NCT Number: NCT05664113

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

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.

Recruiting

Interested in participating?

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Key information

Age range

Up to 22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location status: Recruiting

Location contact

Gabriela Maron, MD

CONTACT

[email protected]

888-226-4343

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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).

OR

  • 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

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.

Treatment and study plan

Fecal Microbiota Transplant (FMT)

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

Other names: FMT

Primary outcomes

  1. Proportion of participants with a serious adverse event occurring within 30 days following FMT

    Time frame: 30 Days

    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
  2. Proportion of participants with a non-serious adverse event occurring within 30 days following FMT

    Time frame: 30 Days

    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
  3. Proportion of participants expressing interest who meet eligibility

    Time frame: 2 years

    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
  4. Proportion of participants recruited in the eligible population

    Time frame: 2 years

    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
  5. Proportion of participants that drop up post-enrollment

    Time frame: 3 years

    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
  6. Proportion of participants providing all protocol required stool samples

    Time frame: 3 years

    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

Secondary outcomes

  1. Proportion of participants with a complete response or a partial response

    Time frame: 180 days

    Complete response or partial response will be a secondary outcome measure for the following groups:

    • FMT for treating a GvHD of the gut following HCT
    • FMT for treating HCT induced gut dysfunction
  2. Percentage of participants who reduce or discontinue steroids at the end of the study

    Time frame: 1 year

    Reduction in dose of steroids will be a secondary outcome measure for the following groups:

    • FMT for treating a GvHD of the gut following HCT
    • FMT for treating HCT induced gut dysfunction

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriela Maron, MD

CONTACT

[email protected]

888-226-4343

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Dec 23, 2022
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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