Comparing Several Strategies to Manage Moderate Acute Malnutrition Among Children From 6 to 24 Months Old
Condition: Moderate Acute Malnutrition
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 3

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.
    

Detailed 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.
    

Intervention name(s): Azythromycin; Inuline and fructo-oligosaccharides; Albendazole; Fortified blend flour
Intervention type(s): Drug; Dietary Supplement; Drug; Dietary Supplement
Intervention description(s): Administration of azythromycin to the child at inclusion (3 days) 20 mgs/kgs/day : three days; Administration of inuline and fructo-oligosaccharides (Synergy1) 2g/day, mixed with the fortified blend flour given to the child through the whole intervention.; Administration of Albendazole at inclusion of the child : 200mgs, one administration; Children from 6 to 11 months : 200 grams / day Children from 12 to 24 months : 300 grams / day
Compostion of the fortified blend flour per 100 grams : either :
Mil (whole grains): 58,56 g/100g, Soybeans (fat meal): 16,54g/100g Peanuts (roasted seeds): 8,75g/100g, Cane sugar: 7,35 g/100g Whole milk (Powder): 7,56g/100g, MSV MAM: 0,28g/100g, iodized salt :0,45g/100g, CaC03: 0,48g/100g,Amylase BAN: 0,03g/100g OR Corn (whole grains): 53,29g/100g, Soybeans (dry seeds): 17,82g/100g, Peanuts (roasted seeds): 9,00 g/100g, Cane sugar: 11,00 Whole milk (Powder): 5,00g/100g, Soybean Oil (Purified): 1,24g/100g, Peanut oil (Purified): 1,13g/100g, MSV MAM: 0,27g/100g, iodized salt: 0,53 g/100g, Ca3(PO4)2: 0,62g/100g, KCl: 0,09g/100g
Other intervention name(s): Antibiotics; Prebiotic; Antiparasitic drug; Lacteal flour
Intervention MeSH terms: Anti-Bacterial Agents; Azithromycin; Albendazole; Antiparasitic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Children; Africa; Metagenomic; Prebiotic; Randomized Controlled Trial; Pragmatic trial; Azithromycin; Cognitive impairment