A multicenter, randomized controlled comparison of three renutrition strategies for the management of moderate acute malnutrition among children aged from 6 to 24 months (the MALINEA project)

Muriel Vray (1, 2) , Boris G Hedible (2) , Pierrick Adam (1) , Laura Tondeur (1) , Alexandre Manirazika (3) , Rindra Randremanana (4) , Halima Maïnassara (5) , André Briend (6, 7) , Cécile Artaud (8) , Cassandre von Platen (8) , Mathias Altmann (9) , Ronan Jambou (10)

1 Epidémiologie des Maladies Emergentes - Emerging Diseases Epidemiology
2 Unité d'Epidémiologie des Maladies Infectieuses
3 Institut Pasteur de Bangui
4 IPM - Unité d'Epidémiologie [Antananarivo, Madagascar]
5 CERMES - Centre de Recherche Médicale et Sanitaire (Niamey, Niger)
6 UCPH - University of Copenhagen = Københavns Universitet
7 University of Tampere [Finland]
8 PIRC - Pôle Intégré de Recherche Clinique
9 ACF - Action contre la Faim
10 IP - Institut Pasteur [Paris]

BACKGROUND: 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. METHODS: To be included, children aged between 6 months and 2 years are preselected based on mid-upper-arm circumference (MUAC) and are included based on a weight-for-height Z-score (WHZ) between - 3 and - 2 standard deviations (SD). As per current protocols, children receive renutrition treatment for 12 weeks and are assessed weekly to determine improvement. The primary endpoint is recovery, defined by a WHZ ≥ - 1.5 SD after 12 weeks of treatment. Data collected include clinical and socioeconomic characteristics, side effects, compliance and tolerance to interventions. Metagenomic analysis of gut microbiota is conducted at inclusion, 3 months, and 6 months. The cognitive development of children is evaluated in Senegal using only the Developmental Milestones Checklist II (DMC II) questionnaire at inclusion and at 3, 6, and 9 months. The data will be correlated with renutrition efficacy and metagenomic data. DISCUSSION: This study will provide new insights for the treatment of MAM, as well as original data on the modulation of gut microbiota during the renutrition process to support (or not) the microbiota hypothesis of malnutrition.

Mots clés: Azithromycin; Metagenomic; Prebiotic; Moderate acute malnutrition; Microbiota

Domaines: Alimentation et Nutrition

Muriel Vray, Boris G Hedible, Pierrick Adam, Laura Tondeur, Alexandre Manirazika, et al.. A multicenter, randomized controlled comparison of three renutrition strategies for the management of moderate acute malnutrition among children aged from 6 to 24 months (the MALINEA project). Trials, 2018, 19 (1), ⟨10.1186/s13063-018-3027-3⟩. ⟨pasteur-01954942⟩