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.
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).
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
Single group
Fecal microbiota transplant (FMT)
DrugFMT 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
Proportion of participants with a serious adverse event occurring within 30 days following FMT
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
Proportion of participants with a non-serious adverse event occurring within 30 days following FMT
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
Proportion of participants expressing interest who meet eligibility
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
Proportion of participants recruited in the eligible population
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
Proportion of participants with a complete response or a partial response
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
Percentage of participants who reduce or discontinue steroids at the end of the study
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
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