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

Epicentre7,356 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

7,356

Conditions

Malnutrition, Child

Interventions

MDFDIETARY_SUPPLEMENT

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.

RUTFDIETARY_SUPPLEMENT

RUTF will be provided to all children on a weekly basis at the health center until programmatic recovery but not thereafter

RUSFDIETARY_SUPPLEMENT

RUSF will be provided on a biweekly basis at the health center until programmatic recovery but not thereafter

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 23 Months

Medical Language ↔ Plain English

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

RECRUITING

Outcomes

Primary Outcomes

Programmatic recovery by 12 weeks from admission

Defined as the proportion of SAM and MAM children achieving a WLZ ≥ -2 AND MUAC ≥ 125mm AND no edema during 2 consecutive visits

Time frame: 12 weeks

Sustained recovery at 24 weeks from admission

Proportion of recovered SAM and MAM children with WLZ ≥ -2 AND MUAC ≥ 125mm AND no edema

Time frame: 24 weeks

Secondary Outcomes

Default

Defined as 2 consecutive missed scheduled program visits

Time frame: 12 weeks

Non-response

Defined as WLZ \< -2 or MUAC \< 125 mm during 2 consecutive visits, or for SAM children only: persistent edema at 12 weeks

Time frame: 12 weeks

Time to recovery

Measured as days from admission to programmatic recovery among recovered children

Time frame: 12 weeks

For MAM children: Deterioration to SAM

Weight-for-height z-score (WHZ) inferior to -3

Time frame: 24 weeks

Change in weight gain

Change in g/kg/day

Time frame: From enrollment to 4, 8 and 12 weeks

Change in weight-for-length Z (WLZ)

Change in WLZ calculated using the 2006 WHO Growth Standards

Time frame: From enrollment to 4, 8 and 12 weeks

Central Contacts

Sheila Isanaka, ScD

CONTACT

sisanaka@hsph.harvard.edu

Data from ClinicalTrials.gov

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