Microbiome-Directed Food for Sustained Recovery From Acute Malnutrition
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-23
SponsorInstitut de Recherche en Sciences de la Sante, Burkina Faso
About this trial
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.
Eligibility criteria
Qualifiers
Age between 6 and 23 months
Moderate wasting: WHZ < -2 and ≥ -3 or MUAC < 125 mm and ≥ 115mm or - Severe wasting: WHZ < -3 or MUAC < 115 mm
Disqualifiers
Bilateral pitting edema
Not eating/lack of appetite
Current illness medical complications requiring inpatient treatment
Presence of any congenital abnormality or underlying chronic disease that may affect growth or risk of infection
Trial design
Treatments tested in this trial
- Microbiome-directed food - MAM
- Ready-to-use supplementary food (RUSF)
- Microbiome-directed food (MDF) - SAM
- Ready-to-use therapeutic food (RUTF)
Treatment groups
6,200 Participants
are divided into 4 treatment groupsSponsors and collaborators
Institut de Recherche en Sciences de la Sante, Burkina Faso
Lead sponsor
Ministry of Health, Burkina Faso
Collaborator
Bill and Melinda Gates Foundation
Collaborator
Source ClinicalTrials.gov