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

RECRUITINGNA

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

NCT06382857•Epicentre

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 1 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•for children with Severe Acute Malnutrition (SAM): MUAC \< 115 mm and/or WLZ \< -3 and/or mild (+) or moderate (++) edema
•for children with Moderate Acute Malnutrition (MAM): 115 mm ≤ MUAC \< 125 mm and/or -3 ≤ WHZ \< -2
•Caregiver providing informed consent

Exclusion Criteria

•Medical complications requiring inpatient treatment, as identified by the national protocol
•Not eating/lack of appetite (as informed by appetite test and investigator judgement)
•Re-admission into the program within 2 months of previous default
•for children with Severe Acute Malnutrition (SAM): Referral from inpatient care (therapeutic feeding center, TFC) or supplementary feeding program (SFP)
•for children with Moderate Acute Malnutrition (MAM): Referral from SAM treatment (TFC or OTP)
•Presence of congenital abnormality or underlying chronic disease that may affect growth or risk of infection
•Known contraindication/ hypersensitivity/allergy to study interventions (chickpea/soy flour, banana, peanut)
•Residence outside the study catchment area or in a non-fixed (e.g. nomadic) community

Locations (1)

Epicentre Niger

Maradi, Niger

Key Dates

Start Date

May 2, 2024

Primary Completion Date

November 1, 2025

Completion Date

February 1, 2026

Last Updated

August 27, 2024

Enrollment

7,356

ESTIMATED participants

Conditions

Malnutrition, Child

Interventions

MDF

DIETARY_SUPPLEMENT

RUTF

DIETARY_SUPPLEMENT

RUSF

DIETARY_SUPPLEMENT

Contacts

Sheila Isanaka, ScD

CONTACT

sisanaka@hsph.harvard.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 27, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients

Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition

Slow Introduction of Nutrition for Ill Malnourished Children

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Double Duty Interventions and Its Impact on Double Burden of Malnutrition in Children Under Five Years