drugset / Trial / NCT03474276
Comparing Several Strategies to Manage Moderate Acute Malnutrition Among Children From 6 to 24 Months Old
Phase 3
Completed
1357 enrolled
Institut Pasteur
Action Contre la Faim · collabCentre de Recherches Médicales et Sanitaires CERMES Niger · collabInstitut Pasteur de Bangui · collabInstitut Pasteur de Dakar · collabInstitut Pasteur de Madagascar · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-01-31
- Primary completion
- 2018-12-31
- Completion
- 2019-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azithromycin | Small molecule | 20 mg/kg | — |
| Comparator | Albendazole | Small molecule | 200 mg | — |