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

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.

Conditions

• Moderate Acute Malnutrition

Interventions

DRUG

Azythromycin

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

DIETARY_SUPPLEMENT

Inuline and fructo-oligosaccharides

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

DRUG

Albendazole

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

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

Sponsors & Collaborators

• Action Contre la Faim

  collaborator OTHER

• Centre de Recherches Médicales et Sanitaires CERMES Niger

  collaborator UNKNOWN

• Institut Pasteur de Madagascar

  collaborator OTHER

• Institut Pasteur de Bangui

  collaborator AMBIG

• Institut Pasteur de Dakar

  collaborator OTHER

• Institut Pasteur

  lead INDUSTRY

Principal Investigators

• Ronan JAMBOU, PhD · Institut Pasteur

• Muriel Vray, phD · Institut Pasteur

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

24 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-01-31

Primary Completion

2018-12-31

Completion

2019-06-30

Countries

• Central African Republic
• Madagascar
• Niger
• Senegal

Study Locations