Clinical Trial

Microbiota Directed Food for Children With Severe Acute Malnutrition

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Summary
Severe acute malnutrition (SAM) refers to a condition characterized by a significant deficit in weight-for-length measurements in children aged 6 to 59 months. It is a crucial public health concern with detrimental effects on child growth, development, and overall well-being. Addressing SAM is crucial to prevent its progression to other childhood morbidity and mortality and to ensure healthy child development. To meet the nutritional requirement of SAM children, icddr,b have come up with a novel intervention named microbiota-directed food (MDF), a ready-to-use therapeutic food. The investigators propose this proof-of-concept trial to establish evidence on the effect of this novel intervention on ponderal growth, microbial and proteomic recovery among the children with SAM in comparison to the standard RUTF.
Trial Details
NCT Number NCT06308848
Lead Sponsor International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators: Washington University School of Medicine
Conditions Severe Acute Malnutrition
Enrollment 256 participants
Start Date 2024-04-15
Primary Completion 2026-10-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-03-13