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)