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Recruiting
NCT05664113
Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation (FMT) for Gastrointestinal Dysfunction in Children Following Hematopoietic Cell Transplant (HCT).
Conditions: Gastro-Intestinal Disorder
Sex: All
Ages: N/A – 22 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 10
Sponsor: St. Jude Children's Research Hospital
Location: St. Jude Children's Research Hospital Memphis Tennessee
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.
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:
* Patient 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.
Source: ClinicalTrials.gov (NCT05664113). StuddyBuddy aggregates publicly available trial information.