Nutrition

Context 

• Frequent relapses
• Gut microbiota could be a target to decrease the risk of relapse
• Proof of concept in Bangladesh (Chen et al, 2021): Promising results in limited sample
• Evidence needed from larger randomized trials to show efficacy of an microbiota-directed food in recovery of children with SAM and MAM in other settings.

Primary objective

To evaluate the efficacy of a microbiota-directed food (MDA) in terms of recovery in the program within 12 weeks and sustained recovery within 24 weeks of admission in children with uncomplicated acute malnutrition in Niger compared with standard ready-to-use supplementary therapeutic foods (RUSF) for SAM and standard supplementary ready-to-use foods (SRTP) for MAM.

Secondary objectives

• Efficacy in terms of nonresponse and program dropout
• Safety in terms of hospitalization, mortality, and serious adverse events
• Effect on child anthropometry and neurocognitive development
• Acceptability and use of the products in the home
• Cost-effectiveness

Methodology

Individually randomized controlled trial stratified by severity of acute malnutrition.

• 2 MAS arms: MDFvs RUTF (Plumpy'nut)
• 2 MAM arms: ACM vs RUSF(Plumpy'sup)

Who’s involved besides MSF?

Harvard University

Country

Niger

Status

Recruitment not started

Tentative End date

December 2024

Our Role

Sponsor, Coordination, study site