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Acceptability of a Microbiome-directed Food in Young Children With Acute Malnutrition

NCT05551819 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2024-04-17

No results posted yet for this study

Summary

This study will compare the acceptability a microbiome-directed food (MDF) with standard formulations of therapeutic/supplementary foods for the treatment of acute malnutrition using a 2 x 2 crossover design.

Conditions

  • Malnutrition, Child

Interventions

DIETARY_SUPPLEMENT

MDF then RUTF/RUSF

Children randomized to feeding order 1: children will be provided MDF for the first two weeks then crossover to consume RUTF/RUSF for a second two weeks.

DIETARY_SUPPLEMENT

RUTF/RUSF then MDF

Children randomized to feeding order 2: children will be provided RUTF/RUSF for the first two weeks then crossover to consume MDF for a second two weeks.

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-10-26
Primary Completion
2023-03-16
Completion
2023-03-16

Countries

  • Niger

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 NCT05551819 on ClinicalTrials.gov