NCT05586139

Microbiome-Directed Food for Sustained Recovery From Acute Malnutrition

Efficacy of a Food Targeting the Microbiota for a Sustained Recovery of Children With Uncomplicated Acute Malnutrition

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6,200 (estimated)
• Sponsor: Institut de Recherche en Sciences de la Sante, Burkina Faso · Other Government
• Sex: All
• Age: 6 Months – 23 Months
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

In this stratified trial, children presenting at the health center and fulfilling the inclusion criteria will be randomly allocated into one of the study groups in a ratio of 1:1:1 for MAM and 1:1 for SAM. The supplementation will be done on daily basis according to the child's weight for a maximum of 12 weeks, at which point the programmatic recovery assessment is done. Those who recovered before or at this point, will be subsequently followed up monthly up to 3 month for sustained recovery assessment. Follow-up visits will be done at the health center every week for severe acute malnutrition (SAM) children and every two weeks for moderate acute malnutrition (SAM) children. At each visit, anthropometric measurements will be performed; a morbidity questionnaire will be administered before the mother/caregiver receives the ration for the following period. For the measurement of adherence, mothers will be asked to bring back empty and unused sachets/packaging of supplements from the last visit. Questions will also be asked to the mother/caregiver on the difficulties encountered during consumption and the adverse events observed following the consumption of the supplements.

Conditions

• Acute Malnutrition With no Complications

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Microbiome-directed food - MAM	Each MAM child will be supplemented with MDF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.
DIETARY_SUPPLEMENT	Ready-to-use supplementary food (RUSF)	Each MAM child will be supplemented with RUSF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.
DIETARY_SUPPLEMENT	Microbiome-directed food (MDF) - SAM	Each SAM child will be supplemented with MDF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.
DIETARY_SUPPLEMENT	Ready-to-use therapeutic food (RUTF)	Each SAM child will be supplemented with RUTF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2022-10-19
• Last updated: 2024-03-13

Locations

1 site across 1 country: Burkina Faso