Malnutrition, Child Clinical Trial
Official title:
Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition
Verified date | April 2024 |
Source | Epicentre |
Contact | Sheila Isanaka, ScD |
sisanaka[@]hsph.harvard.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 7356 |
Est. completion date | February 1, 2026 |
Est. primary completion date | November 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 23 Months |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Niger | Epicentre Niger | Maradi |
Lead Sponsor | Collaborator |
---|---|
Epicentre | Epicentre, Niger, Ministry of Public Health and Social Affairs, Niger, National Nutrition Direction, Niger, Regional Direction of Public Health, Maradi |
Niger,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 12 weeks | |
Primary | Sustained recovery at 24 weeks from admission | Proportion of recovered SAM and MAM children with WLZ = -2 AND MUAC = 125mm AND no edema | 24 weeks | |
Secondary | Default | Defined as 2 consecutive missed scheduled program visits | 12 weeks | |
Secondary | Non-response | Defined as WLZ < -2 or MUAC < 125 mm during 2 consecutive visits, or for SAM children only: persistent edema at 12 weeks | 12 weeks | |
Secondary | Time to recovery | Measured as days from admission to programmatic recovery among recovered children | 12 weeks | |
Secondary | For MAM children: Deterioration to SAM | Weight-for-height z-score (WHZ) inferior to -3 | 24 weeks | |
Secondary | Change in weight gain | Change in g/kg/day | From enrollment to 4, 8 and 12 weeks | |
Secondary | Change in weight-for-length Z (WLZ) | Change in WLZ calculated using the 2006 WHO Growth Standards | From enrollment to 4, 8 and 12 weeks | |
Secondary | Change in length-for-age Z (LAZ) | Change in LAZ calculated using the 2006 WHO Growth Standards | From enrollment to 4, 8 and 12 weeks | |
Secondary | Change in weight-for-age Z (WAZ) | Change in WAZ calculated using the 2006 WHO Growth Standards | From enrollment to 4, 8 and 12 weeks | |
Secondary | Change in MUAC | Change in mm | From enrollment to 4, 8 and 12 weeks | |
Secondary | Serious adverse events | Combined safety endpoint, including hospitalization and death | 24 weeks | |
Secondary | Hospitalization | Inpatient stay > 24h | 24 weeks | |
Secondary | Death | All-cause mortality | 24 weeks | |
Secondary | Motor, cognitive, language, social-emotional, and mental health skills | As measured by the Caregiver Reported Early Development Instrument (CREDI) | 24 weeks | |
Secondary | Cost effectiveness | As defined by the incremental cost per child recovered and per child sustained recovered | 24 weeks | |
Secondary | Dietary intake | As measured by 24h recall | 24 weeks | |
Secondary | Adherence | Defined as the sum of sachets returned used divided by the total number of sachets distributed | 12 weeks | |
Secondary | Microbiome profile at enrollment, week 4, program discharge, and study discharge | Defined as PCR-confirmed enteric viral, bacterial, and protozoan pathogens present | 24 weeks | |
Secondary | Plasma proteome profile at enrollment, week 4, program discharge, and study discharge | Defined as circulating plasma proteins (IGFBP-2, thrombospondin-5, granulysin, GDF-15, and MMP-8) | 24 weeks | |
Secondary | Environmental enteric dysfunction at enrollment, program discharge, and study discharge | Measured by anti-LPS IgA and IgG; anti-flagellin IgA and IgG; sCD14; I-FABP; myeloperoxidase (MPO); and calprotectin | 24 weeks | |
Secondary | Change of fat mass and fat-free mass at program discharge and study discharge | Measured by deuterium dilution | 24 weeks | |
Secondary | Micronutrient status at enrollment, program discharge and study discharge | Defined as ferritin; soluble transferrin binding protein; alpha-tocopherol; retinol; folate; and vitamin B12 | 24 weeks | |
Secondary | Immuno-sufficiency at week 2, week 4, program discharge, week 12 and study discharge (SAM only) | As defined by T-cell receptor excision circles (TRECs) and kappa-receptor excision circles (KRECs) | 24 weeks |
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