NCT06382857

Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 7,356 (estimated)
• Sponsor: Epicentre · Academic / Other
• Sex: All
• Age: 6 Months – 23 Months
• Healthy volunteers: Not accepted

Summary

This study is an individually randomized controlled trial comparing microbiome-directed foods to standard nutritional therapy among children aged 6 to \< 24 months with uncomplicated acute malnutrition in terms of programmatic recovery by 12 weeks from admission and sustained recovery at 24 weeks from admission.

Conditions

• Malnutrition, Child

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	MDF	MDF will be provided to children on a weekly basis for children with SAM and bi-weekly basis for children with MAM at the health center until programmatic recovery but not thereafter.
DIETARY_SUPPLEMENT	RUTF	RUTF will be provided to all children on a weekly basis at the health center until programmatic recovery but not thereafter
DIETARY_SUPPLEMENT	RUSF	RUSF will be provided on a biweekly basis at the health center until programmatic recovery but not thereafter

Timeline

• Start date: 2024-05-02
• Primary completion: 2025-11-01
• Completion: 2026-02-01
• First posted: 2024-04-24
• Last updated: 2024-08-27

Locations

1 site across 1 country: Niger