Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation (FMT) for Gastrointestinal Dysfunction in Children Following Hematopoietic Cell Transplant (HCT).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fecal microbiota transplant (FMT).
- Who it may be relevant to
- Registry conditions: Gastro-Intestinal Disorder. Basic parameters: up to 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Participants will be eligible to receive an FMT on or after Day +30 post-HCT. FMT will be performed using FMP material obtained from OpenBiome. 60 mL of FMP will be administered via NJ tube and 250 mL via colonoscopy. A second FMT may be performed at least 14 days after the initial FMT in GI clinical symptoms have partially improved or have not changed. The second FMT will be administered using the same procedure as in the initial FMT
Interventions
- Drug Fecal microbiota transplant (FMT)
FMT 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
Primary outcome measures
- Proportion of participants with a serious adverse event occurring within 30 days following FMT [Time frame: 30 Days]
- Proportion of participants with a non-serious adverse event occurring within 30 days following FMT [Time frame: 30 Days]
- Proportion of participants expressing interest who meet eligibility [Time frame: 2 years]
- Proportion of participants recruited in the eligible population [Time frame: 2 years]
- Proportion of participants that drop up post-enrollment [Time frame: 3 years]
- Proportion of participants providing all protocol required stool samples [Time frame: 3 years]
Secondary outcome measures (2)
- Proportion of participants with a complete response or a partial response [Time frame: 180 days]
- Percentage of participants who reduce or discontinue steroids at the end of the study [Time frame: 1 year]
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:
- 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).
OR
- Current or prolonged GI dysfunction following HCT, defined as having diarrhea or loose stools >/= 4 weeks with at least one of the following:
- Requiring NG or G-tube feeds
- Requiring TPN or IVF for more than 4 weeks
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- St. Jude Children's Research Hospital — Memphis
Identifiers
NCT: NCT05664113 · NEWGUT · NCI-2024-02553