Malnutrition, Child
Conditions
Keywords
Malnutrition, SAM, MAM, Child, MDF, Microbiome
Brief 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.
Interventions
DIETARY_SUPPLEMENTMDF
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.
DIETARY_SUPPLEMENTRUTF
RUTF will be provided to all children on a weekly basis at the health center until programmatic recovery but not thereafter
DIETARY_SUPPLEMENTRUSF
RUSF will be provided on a biweekly basis at the health center until programmatic recovery but not thereafter
Sponsors
Epicentre, Niger
National Nutrition Direction, Niger
Ministry of Public Health and Social Affairs, Niger
Regional Direction of Public Health, Maradi
Epicentre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 23 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Programmatic recovery by 12 weeks from admission | 12 weeks | Defined as the proportion of SAM and MAM children achieving a WLZ ≥ -2 AND MUAC ≥ 125mm AND no edema during 2 consecutive visits |
| Sustained recovery at 24 weeks from admission | 24 weeks | Proportion of recovered SAM and MAM children with WLZ ≥ -2 AND MUAC ≥ 125mm AND no edema |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-response | 12 weeks | Defined as WLZ \< -2 or MUAC \< 125 mm during 2 consecutive visits, or for SAM children only: persistent edema at 12 weeks |
| Time to recovery | 12 weeks | Measured as days from admission to programmatic recovery among recovered children |
| For MAM children: Deterioration to SAM | 24 weeks | Weight-for-height z-score (WHZ) inferior to -3 |
| Change in weight gain | From enrollment to 4, 8 and 12 weeks | Change in g/kg/day |
| Change in weight-for-length Z (WLZ) | From enrollment to 4, 8 and 12 weeks | Change in WLZ calculated using the 2006 WHO Growth Standards |
| Change in length-for-age Z (LAZ) | From enrollment to 4, 8 and 12 weeks | Change in LAZ calculated using the 2006 WHO Growth Standards |
| Change in weight-for-age Z (WAZ) | From enrollment to 4, 8 and 12 weeks | Change in WAZ calculated using the 2006 WHO Growth Standards |
| Change in MUAC | From enrollment to 4, 8 and 12 weeks | Change in mm |
| Serious adverse events | 24 weeks | Combined safety endpoint, including hospitalization and death |
| Hospitalization | 24 weeks | Inpatient stay \> 24h |
| Immuno-sufficiency at week 2, week 4, program discharge, week 12 and study discharge (SAM only) | 24 weeks | As defined by T-cell receptor excision circles (TRECs) and kappa-receptor excision circles (KRECs) |
| Motor, cognitive, language, social-emotional, and mental health skills | 24 weeks | As measured by the Caregiver Reported Early Development Instrument (CREDI) |
| Cost effectiveness | 24 weeks | As defined by the incremental cost per child recovered and per child sustained recovered |
| Dietary intake | 24 weeks | As measured by 24h recall |
| Adherence | 12 weeks | Defined as the sum of sachets returned used divided by the total number of sachets distributed |
| Microbiome profile at enrollment, week 4, program discharge, and study discharge | 24 weeks | Defined as PCR-confirmed enteric viral, bacterial, and protozoan pathogens present |
| Plasma proteome profile at enrollment, week 4, program discharge, and study discharge | 24 weeks | Defined as circulating plasma proteins (IGFBP-2, thrombospondin-5, granulysin, GDF-15, and MMP-8) |
| Environmental enteric dysfunction at enrollment, program discharge, and study discharge | 24 weeks | Measured by anti-LPS IgA and IgG; anti-flagellin IgA and IgG; sCD14; I-FABP; myeloperoxidase (MPO); and calprotectin |
| Change of fat mass and fat-free mass at program discharge and study discharge | 24 weeks | Measured by deuterium dilution |
| Micronutrient status at enrollment, program discharge and study discharge | 24 weeks | Defined as ferritin; soluble transferrin binding protein; alpha-tocopherol; retinol; folate; and vitamin B12 |
| Death | 24 weeks | All-cause mortality |
| Default | 12 weeks | Defined as 2 consecutive missed scheduled program visits |
Countries
Niger
Contacts
Primary ContactSheila Isanaka, ScD
Outcome results
None listed