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Clinical Trial Summary

The aim of this open-label randomized controlled trial conducted in four African countries (Madagascar, Niger, Central African Republic and Senegal) is to compare three strategies of renutrition for moderate acute malnutrition (MAM) in children based on modulation of the gut microbiota with enriched flours alone, enriched flours with prebiotics or enriched flours coupled with antibiotic treatment. Cognitive development of children (Senegal) will also be studied and compared.

Clinical Trial Description

The main objective of this study is to improve the nutrition strategy used to take in charge moderate acute malnutrition (MAM) which is the major milestone before severe malnutrition. This will be based on the modulation of the gut microbiota with adjunct product added to standard nutrition flours.

The purpose of the MALINEA study is to compare three management strategies for Moderate Acute Malnutrition (MAM) in children aged between 6 months and 2 years old on recovery defined by a weight/size gain at 3 months.

The 3 groups will be compared on several anthropometric measurements [Weight, length, Mid Upper Arm Circumference (MUAC)], clinical characteristics, adherence and tolerance to interventions between before and after a 3 months intervention Cognitive development of children (Senegal) will also be studied and compared, at inclusion, 3 months and 6 months after inclusion.

The investigators will also investigate the microbiomes of malnourished children at inclusion and at 3 and 6 months after inclusion to compare it to the ones of normonourished children. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03474276
Study type Interventional
Source Institut Pasteur
Contact Muriel Vray, PhD
Phone +221 33 839 92 47
Status Recruiting
Phase Phase 3
Start date January 31, 2018
Completion date March 30, 2019

See also
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Completed NCT01115647 - Treating Moderate Malnutrition in 6-24 Months Old Children N/A
Completed NCT01898871 - Effectiveness of Nutritional Products to Treat Moderate Acute Malnutrition Phase 2
Completed NCT01147198 - Ready to Use Supplementary Food in Moderate Childhood Malnutrition N/A
Recruiting NCT03146897 - Comparison of Four Different Supplementary Foods in the Treatment of Moderate Acute Malnutrition N/A