Using fecal microbiota transplantation to treat gastrointestinal issues in children after stem cell transplants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the feasibility, safety, and potential efficacy of fecal microbiota transplantation (FMT) for children experiencing gastrointestinal dysfunction following hematopoietic cell transplantation (HCT). Participants aged 22 years or younger who have undergone HCT and are experiencing specific gastrointestinal symptoms will receive FMT using material from OpenBiome. The procedure involves administering FMT via a nasojejunal tube and colonoscopy, with the possibility of a second treatment if symptoms do not improve. The study aims to assess both the safety and potential benefits of this innovative approach in managing gut-related complications post-transplant.

Why it matters

Who can join: the full rules

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.

Where it's running

• St. Jude Children's Research Hospital
  Memphis, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Gabriela Maron, MD — St. Jude Children's Research Hospital
• Study coordinator: Gabriela Maron, MD
• Email: referrainfo@stjude.org
• Phone: 888-226-4343

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.