Trial | NCT03474276  Report issue

Title

Comparing Several Strategies to Manage Moderate Acute Malnutrition Among Children From 6 to 24 Months Old
A Multi-center, Randomized Controlled Comparison of Three Renutrition Strategies for the Management of Moderate Acute Malnutrition Among Children From 6 to 24 Months (Madagascar, Niger, Central African Republic and Senegal)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    1357
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.
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 Started
Jan 31
2018
Primary Completion
Dec 31
2018
Study Completion
Jun 30
2019
Last Update
May 24
2022

Drug Azythromycin

Administration of azythromycin to the child at inclusion (3 days) 20 mgs/kgs/day : three days

  • Other names: Antibiotics

Dietary Supplement Inuline and fructo-oligosaccharides [inulin, fructo-oligosaccharide]

Administration of inuline and fructo-oligosaccharides (Synergy1) 2g/day, mixed with the fortified blend flour given to the child through the whole intervention.

  • Other names: Prebiotic

Drug Albendazole

Administration of Albendazole at inclusion of the child : 200mgs, one administration

  • Other names: Antiparasitic drug

Dietary Supplement Fortified blend flour

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 names: Lacteal flour

Control group Active Comparator

Fortified Blended Flour (in association with a single dose of Albendazole at inclusion for children older than 12 months). 200 grams / day for children between 6 and 11 months. 300 grams / day for children aged from 12 to 24 months old.

Azythromycin Active Comparator

Fortified Blended Flour (in association with a single dose of Albendazole at inclusion for children older than 12 months) associated to Azythromycin, 20mg/kgs/days during the three first days of the study.

Prebiotic Active Comparator

Fortified Blended Flour mixed with Inuline and fructo-oligosaccharides (Synergy1) 2g/day, given to the child through the whole intervention (in association with a single dose of Albendazole at inclusion for children older than 12 months)

Criteria 

Inclusion Criteria:

Children aged from 6 to 24 months olds.
Moderate acute malnutrition defined by a -3 ≤ Weight/Height z-score < -2 SD.
Written informed consent of parents or legal guardian.
Child able to be brought back to the centre on the two following days of inclusion.
Child able to be followed up during at least three months.

Exclusion Criteria:

Severe malnutrition defined by a mid upper arm circumference < 115 mm OR Weight/Height z-score < -3 SD OR presence of nutritional oedema.
Clinical complications or according to the physician any clinical sign requiring care outside of the recruitment centre (referral to specialised centre or hospitalisation)
Diarrhea with mucus and bloody stools.
Current incompatible treatment : Antacids, Cetirizine, Digoxin, Ergotamine, Azidothymidine.
Known hypersensitivity to macrolides or albendazole (or one of its components)
Known allergy to enriched flours or prebiotics used in the study, or one of its components.
No Results Posted