Comparing Several Strategies to Manage Moderate Acute Malnutrition Among Children From 6 to 24 Months Old

Institut Pasteur1,357 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,357

Conditions

Moderate Acute Malnutrition

Interventions

AzythromycinDRUG

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

Inuline and fructo-oligosaccharidesDIETARY_SUPPLEMENT

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

AlbendazoleDRUG

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

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 24 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (4)

Institut Pasteur de bangui - Centre Nutritionnel de Gbangouma et Centre de Santé Saint-Joseph

Bangui, Central African Republic

Institut Pasteur de Madagascar - CRENAM Andohotapenaka et Centre de Santé Mitia

Antananarivo, Madagascar

Centre de santé intégré ACF de Tchake et d'Issawanne

Maradi, Niger

Institut Pasteur de Dakar - Poste de Santé Hamo V

Dakar, Guédiawaye, Senegal

Outcomes

Primary Outcomes

Recovery at three month

Recovery at three months, defined by: Weight/Size Z-score ≥ -1.5 SD measured at 2 following consultations without hospitalization, transfer, death or lost to follow up

Time frame: Three month

Secondary Outcomes

Cognitive-motor development (Senegal)

Developmental Milestones Checklist II (DMC II) questionnaire to evaluate participating children cognitive and motor abilities.

Time frame: Baseline, three, six and nine months after inclusion

Comparison of the Operational Taxonomic Unit composition of stool samples according to the nutritional status

Each sample will be ADN extracted using Quiagen technology 16S and 18S amplification will be conducted following Hughert et al. (2014) and Tang et al. (2015). PCR products will be sequenced using NGS Illumina plateform. Sequences will be analyzed using Mothur 1.37.6 software and Silva data base (https://www.arb-silva.de/browser). OTU (Operational Taxonomic Unit) composition will be determined for each sample. OTU composition of samples from well and malnourished children will be compared using mann whitney test, and shift in OTUs during renutrition will be analysed using survival analysis.

Time frame: Baseline, three and six months after inclusion

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.