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NOT YET RECRUITING
NCT05586139
NA

Microbiome-Directed Food for Sustained Recovery From Acute Malnutrition

Sponsor: Institut de Recherche en Sciences de la Sante, Burkina Faso

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

6 Months - 23 Months

Study Type

INTERVENTIONAL

Enrollment

6200

Start Date

2024-10

Completion Date

2026-12

Last Updated

2024-03-13

Healthy Volunteers

No

Interventions

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.

Locations (1)

LANOU Hermann Bienou

Ouagadougou, Kadiogo, Burkina Faso