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Session: Late Breaking/Rapid Science Oral Session

(LB01-02-24) Acceptability of Microbiota-Directed Complementary Foods in Treating Indian Children With Moderate Acute Malnutrition – eACT-MAM Pre-proof of Concept Study

Tuesday, July 2, 2024
8:24 AM – 8:36 AM CT
Location:  W183
Objectives: Children with moderate acute malnutrition (MAM), if not managed early and effectively, can end up with severe acute malnutrition (SAM) that has a high risk of mortality. In India, there are no standard guidelines for treatment of MAM. Previous research has shown that MAM children have impaired growth of their gut microbiota which persist despite of conventional nutritional therapies. Recent studies in Bangladesh showed that microbiota-directed complementary foods (MDCF) can repair gut microbiota similar to chronologically age-matched healthy children which can result into improved growth outcomes.

The present study plans to evaluate the acceptability and feasibility of supplementing shelf-stable formulation of MDCF in Indian children with MAM as compared to a locally prepared ready to use supplementary food (RUSF) in three geographically distinct  populations.

Methods: This pre-proof of concept, multicentric, open-labelled, age-stratified, randomised controlled study was done in children with MAM aged 6-18 months. After a run-in period of 2 weeks, the participants were supplemented with freshly prepared MDCF or premixed RUSF (18-25 gm twice daily, approx. 30% of the energy requirement) for 4î weeks through direct observation. Stool samples were collected, aliquoted and stored in dry shippers within 30 min of defecation before long term storage at -800C for microbiome analysis. Anthropometric measurements were done at baseline and endline and acceptability evaluation was done at the end of every week.

Results: Total 240 children were randomised to receive either MDCF or RUSF of which 221 completed 4 weeks follow up. MDCF and RUSF interventions was associated with good acceptability in 89.2% and 92.6% participants and good-to-high compliance in 83% and 79.9% of participants, respectively. Approximately 96% stool samples were collected, aliquoted and stored within 30 minutes of defecation. WLZ improved from -2.3(0.27) at baseline to -1.99(0.44) in MDCF group and -2.07(0.43) in RUSF group at end of 4 weeks of intervention.

Conclusions: MDCF has good acceptability in Indian MAM children under two years of age. The pre POC study demonstrates feasibility to conduct a long-term supplementation study in this population with stringent criteria for stool sample collection.

Funding Sources: Sun Pharma Advanced Research Company, India