St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Location status: Recruiting
NCT Number: NCT05664113
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.
Interested in participating?
Request InfoUp to 22 year
All sexes
Interventional
Phase 1
Memphis, Tennessee, 38105, United States
Location status: Recruiting
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
OR
Exclusion criteria
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
Other names: FMT
Time frame: 30 Days
Serious adverse events will be a primary outcome measure for the following groups:
Time frame: 30 Days
Non-serious adverse events will be a primary outcome measure for the following groups:
Time frame: 2 years
Participant eligibility will be a primary outcome measure for the following groups:
Time frame: 2 years
Participant recruitment will be a primary outcome measure for the following groups:
Time frame: 3 years
Participant retention will be a primary outcome measure for the following groups:
Time frame: 3 years
Stool specimens will be a primary outcome measure for the following groups:
Time frame: 180 days
Complete response or partial response will be a secondary outcome measure for the following groups:
Time frame: 1 year
Reduction in dose of steroids will be a secondary outcome measure for the following groups:
Contact information is provided by the study sponsor or research team.
St. Jude Children's Research Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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