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

Recruiting now · Not applicable

Conditions studied: Malnutrition, Child

In brief

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.

Key facts

Study ID

NCT06382857

Run by

Epicentre

People needed

7356

Starts

2024-05-02

Expected to finish

2026-02-01

Last updated by the study team

2024-08-27

Who can join

Age: 1 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Epicentre Niger — Maradi, Niger (enrolling)

Full record on ClinicalTrials.gov

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