MedTrace Logo

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

NCT06382857 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7356

Last updated 2024-08-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Epicentre, Niger

    collaborator UNKNOWN

  • National Nutrition Direction, Niger

    collaborator UNKNOWN

  • Ministry of Public Health and Social Affairs, Niger

    collaborator UNKNOWN

  • Regional Direction of Public Health, Maradi

    collaborator UNKNOWN

  • Epicentre

    lead OTHER

Principal Investigators

  • Rebecca Grais, PhD · Epicentre

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
2024-05-02
Primary Completion
2025-11-01
Completion
2026-02-01

Countries

  • Niger

Study Locations

More Related Trials

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 NCT06382857 on ClinicalTrials.gov