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Microbiome-Directed Food for Sustained Recovery From Acute Malnutrition

NCT05586139 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6200

Last updated 2024-03-13

No results posted yet for this study

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.

Conditions

  • Acute Malnutrition With no Complications

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.

Sponsors & Collaborators

  • Ministry of Health, Burkina Faso

    collaborator OTHER_GOV

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Institut de Recherche en Sciences de la Sante, Burkina Faso

    lead OTHER_GOV

Principal Investigators

  • Seni KOUANDA, MD., PhD · Institut de Recherche en Sciences de la Santé, Burkina-Faso

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
23 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2026-08-31
Completion
2026-12-31

Countries

  • Burkina Faso

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05586139 on ClinicalTrials.gov