Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Fecal Microbiota Transplantation for Severe Acute Malnutrition: A Randomized, Placebo-controlled, Pilot Study
Brief Summary:
This single-center, randomized, double-blinded trial will compare the safety and efficacy of FMT given enema in subjects 18-60 months of age with uncomplicated, non-edematous SAM not responsive to standard therapy. Subjects must meet inclusion criteria, no exclusion criteria prior to randomization. Subjects will then be randomized by stratified random sampling (by age, diarrhea, MUAC and hyponatremia) in a 1:1 ratio at each site to 1 of 2 treatment groups:
Subjects will be evaluated through 56 days (±5) after randomization for primary outcomes (safety) as well as secondary outcomes (nutritional, clinical and microbiological response). See definition under endpoints/outcome measures above).
Stool samples will be collected at enrollment and through days 3, 7, 14, 21, 42 and 56. Samples will be used for microbiome determination and other exploratory microbiological endpoints. An aliquot of donor stool will also be stored for microbiome determination and other exploratory microbiological endpoints and assessment of newly acquired infectious agents.