protocolSection identificationModule nctId: NCT06382857, orgStudyIdInfo id: 823779-MDF Niger, briefTitle: Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2025-11-01, completionDateStruct date: 2026-02-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Epicentre, class: OTHER, collaborators name: Epicentre, Niger, collaborators name: National Nutrition Direction, Niger, collaborators name: Ministry of Public Health and Social Affairs, Niger, collaborators name: Regional Direction of Public Health, Maradi, descriptionModule briefSummary: 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., conditionsModule conditions: Malnutrition, Child, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 7356, type: ESTIMATED, armsInterventionsModule interventions name: MDF, interventions name: RUTF, interventions name: RUSF, outcomesModule primaryOutcomes measure: Programmatic recovery by 12 weeks from admission, primaryOutcomes measure: Sustained recovery at 24 weeks from admission, secondaryOutcomes measure: Default, secondaryOutcomes measure: Non-response, secondaryOutcomes measure: Time to recovery, secondaryOutcomes measure: For MAM children: Deterioration to SAM, secondaryOutcomes measure: Change in weight gain, secondaryOutcomes measure: Change in weight-for-length Z (WLZ), secondaryOutcomes measure: Change in length-for-age Z (LAZ), secondaryOutcomes measure: Change in weight-for-age Z (WAZ), secondaryOutcomes measure: Change in MUAC, secondaryOutcomes measure: Serious adverse events, secondaryOutcomes measure: Hospitalization, secondaryOutcomes measure: Death, secondaryOutcomes measure: Motor, cognitive, language, social-emotional, and mental health skills, secondaryOutcomes measure: Cost effectiveness, secondaryOutcomes measure: Dietary intake, secondaryOutcomes measure: Adherence, secondaryOutcomes measure: Microbiome profile at enrollment, week 4, program discharge, and study discharge, secondaryOutcomes measure: Plasma proteome profile at enrollment, week 4, program discharge, and study discharge, secondaryOutcomes measure: Environmental enteric dysfunction at enrollment, program discharge, and study discharge, secondaryOutcomes measure: Change of fat mass and fat-free mass at program discharge and study discharge, secondaryOutcomes measure: Micronutrient status at enrollment, program discharge and study discharge, secondaryOutcomes measure: Immuno-sufficiency at week 2, week 4, program discharge, week 12 and study discharge (SAM only), eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 23 Months, stdAges: CHILD, contactsLocationsModule locations facility: Epicentre Niger, status: RECRUITING, city: Maradi, country: Niger, contacts name: Ousmane Guindo, MD, role: CONTACT, email: ousmane.guindo@epicentre.msf.org, contacts name: Ibrahim Ngoumboute, MD, role: CONTACT, email: ibrahim.ngoumboute@epicentre.msf.org, geoPoint lat: 13.5, lon: 7.10174, hasResults: False