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Microbiome-Directed Food for Sustained Recovery From Acute Malnutrition

Study acronym: MDF
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated March 13, 2024 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Aug 31, 2024 to Aug 2026v2 Show 6 more changesShow less
    • Start date: Jan 16, 2023 to Oct 2024
    • Enrollment target: 7100 to 6200
    • Study completion date: Dec 31, 2024 to Dec 2026
    • Interventions: Locally available food (Dietary Supplement), Microbiome-directed food (MDF) - SAM (Dietary Supplement), Microbiome-directed food - MAM… to Microbiome-directed food (MDF) - SAM (Dietary Supplement), Microbiome-directed food - MAM (Dietary Supplement), Ready-to-use supplementary…
    • Study description expanded, about 96 words
    • Study arms: 5 to 4
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this experimental study is to test the efficacy of a new formulation - The microbiome-directed food (MDF) to treat acute malnutrition among children aged 6 to 23 months. The main questions are: * Does treating children with moderate or severe uncomplicated malnutrition using MDF leads to higher programmatic recovery rate compared to standard of care ? * Does treating children with moderate or severe uncomplicated malnutrition using MDF leads to higher sustained recovery rate compared to standard of care ? The MDF will be compared to Ready-to-use supplementary food (RUSF) for moderately malnourished children, and to Ready-to-use therapeutic food (RUTF) for severely malnourished children to see the effects on recovery and sustained recovery rate.
Trial Details
NCT Number NCT05586139
Lead Sponsor Institut de Recherche en Sciences de la Sante, Burkina Faso
Collaborators: Ministry of Health, Burkina Faso, Bill and Melinda Gates Foundation
Conditions
(from sponsor)		 Acute Malnutrition With no Complications
Enrollment 6,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov