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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeUp to 22
SponsorSt. Jude Children's Research Hospital

About this trial

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

Qualifiers

Age < 22 years old.

Received an allogeneic HCT greater than or equal to 30 days prior to enrollment

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).

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Fecal microbiota transplant (FMT)

Treatment groups

10 Participants
are divided into 2 treatment groups