Clinical Trial: Fecal Microbiota Transplantation for Severe Acute Malnutrition

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:

  • FMT by enema: 10mL/kg (maximum 60mL) of donor fecal material will be infused.
  • Placebo by enema: 10mL/kg (maximum 60mL) of placebo material will be infused.

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.


Detailed Summary:
Sponsor: Microbiome Health Research Institute

Current Primary Outcome: Safety of FMT compared to placebo delivered by enema [ Time Frame: 56 days ]

Proportion of participants with a severe adverse event (SAE) grade 2 or above (according to NIH grading)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Stable engraftment of donor microbiota [ Time Frame: 56 days ]
    Stable engraftment will be defined with the Jensen-Shannon Divergence (JSD) between the bacteria community measured in the donor and recipient. Engraftment scores will be defined by the ratio between the JSD in comparison between the recipient and donor and the recipient and other healthy donors not providing material for their FMT.
  • Normalization of leptin, a biomarker correlated with disease status and mortality in SAM [ Time Frame: 56 days ]
    Serology collected at baseline and end-line will be cryopreserved and analyzed by immunoassay for leptin, a biomarker predicting survival in SAM.


Original Secondary Outcome: Same as current

Information By: Microbiome Health Research Institute

Dates:
Date Received: December 12, 2016
Date Started: June 1, 2017
Date Completion: September 2017
Last Updated: March 15, 2017
Last Verified: March 2017