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

• Status: Completed
• Trial end date: 2019-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Institut Pasteur
• Collaborators: Action Contre la Faim; Centre de Recherches Médicales et Sanitaires CERMES Niger; Institut Pasteur de Bangui; Institut Pasteur de Dakar; Institut Pasteur de Madagascar
• Treatments: Albendazole; Anti-Bacterial Agents; Antiparasitic Agents; Azithromycin

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.