Acute Malnutrition With no Complications
Conditions
Brief summary
The goal of this experimental study is to test the efficacy of a new formulation - The microbiome-directed food (MDF) to treat acute malnutrition among children aged 6 to 23 months. The main questions are: * Does treating children with moderate or severe uncomplicated malnutrition using MDF leads to higher programmatic recovery rate compared to standard of care ? * Does treating children with moderate or severe uncomplicated malnutrition using MDF leads to higher sustained recovery rate compared to standard of care ? The MDF will be compared to Ready-to-use supplementary food (RUSF) for moderately malnourished children, and to Ready-to-use therapeutic food (RUTF) for severely malnourished children to see the effects on recovery and sustained recovery rate.
Detailed description
In this stratified trial, children presenting at the health center and fulfilling the inclusion criteria will be randomly allocated into one of the study groups in a ratio of 1:1:1 for MAM and 1:1 for SAM. The supplementation will be done on daily basis according to the child's weight for a maximum of 12 weeks, at which point the programmatic recovery assessment is done. Those who recovered before or at this point, will be subsequently followed up monthly up to 3 month for sustained recovery assessment. Follow-up visits will be done at the health center every week for severe acute malnutrition (SAM) children and every two weeks for moderate acute malnutrition (SAM) children. At each visit, anthropometric measurements will be performed; a morbidity questionnaire will be administered before the mother/caregiver receives the ration for the following period. For the measurement of adherence, mothers will be asked to bring back empty and unused sachets/packaging of supplements from the last visit. Questions will also be asked to the mother/caregiver on the difficulties encountered during consumption and the adverse events observed following the consumption of the supplements.
Interventions
DIETARY_SUPPLEMENTMicrobiome-directed food - MAM
Each MAM child will be supplemented with MDF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.
DIETARY_SUPPLEMENTReady-to-use supplementary food (RUSF)
Each MAM child will be supplemented with RUSF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.
DIETARY_SUPPLEMENTMicrobiome-directed food (MDF) - SAM
Each SAM child will be supplemented with MDF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.
DIETARY_SUPPLEMENTReady-to-use therapeutic food (RUTF)
Each SAM child will be supplemented with RUTF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.
Sponsors
Ministry of Health, Burkina Faso
Bill and Melinda Gates Foundation
Institut de Recherche en Sciences de la Sante, Burkina Faso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Individually randomized and controlled trial, Stratified by severity of malnutrition: * 2 arms for Severe Acute malnutrition * 2 arms for Moderate acute Malnutrition
Eligibility
Sex/Gender
ALL
Age
6 Months to 23 Months
Healthy volunteers
No
Inclusion criteria
* Age between 6 and 23 months * Moderate wasting: WHZ \< -2 and ≥ -3 or MUAC \< 125 mm and ≥ 115mm or - Severe wasting: WHZ \< -3 or MUAC \< 115 mm
Exclusion criteria
* Bilateral pitting edema * Not eating/lack of appetite * Current illness medical complications requiring inpatient treatment * Presence of any congenital abnormality or underlying chronic disease that may affect growth or risk of infection * Known contraindication/hypersensitivity/allergy to MDCF of RUSF ingredients (chickpea flour, soy flour, banana, peanut) * Relapse from MAM treatment or transfer from SAM treatment * Children recently (\<2 months) or enrolled in a nutrition program * Residence outside the study area
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained recovery defined by WHZ ≥ - 2 z-score or MUAC ≥ 125 mm | 24 weeks from admission to the supplementation program | Children who sustain recovery (WHZ ≥ - 2 z-score or MUAC ≥ 125 mm) up to 24 weeks |
| Programmatic recovery defined by Weight-for-height (WHZ) ≥ - 2 z-score or mid-upper arm circumference (MUAC) ≥ 125 mm | 12th weeks from admission to the supplementation program | Moderate cute malnutrition is defined by Weight-for-height (WHZ) \< - 2 z-score or mid-upper arm circumference (MUAC) \< 125 mm. Higher WHZ z-score (≥ - 2) or mid-upper arm circumference (MUAC) ≥ 125 mm means better outcome synonym of recovery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in Weight-for-height (WHZ) z-score | 12 weeks from admission to the supplementation program | (WHZ z-score at admission) - (WHZ z-score at 12 weeks) |
| Mean change in Weight-for-age (WAZ) z-score | 12 weeks from admission to the supplementation program | (WAZ z-score at admission) - (WAZ z-score at 12 weeks) |
| Mean change in Height-for-age (HAZ) z-score | 12 weeks from admission to the supplementation program | (HAZ z-score at admission) - (HAZ z-score at 12 weeks) |
| Dropouts | 12 weeks | Lost to follow up |
| Non-response defined by WHZ < -2 z-score, or a MUAC < 125 mm | 12 weeks | Children who failed to attain a weight-for-height (WHZ) ≥ - 2 z-score or mid-upper arm circumference (MUAC) ≥ 125 mm |
| Complications | up to 12 weeks | * Edema * Fever \>39°C or hypothermia \<35°C * Severe dehydration * Repeated or incessant vomiting * Severe respiratory problem (IMCI criteria) * severe anemia (significant pallor with difficulty of breathing) * Severe malaria * Abscess or extensive skin lesions * Very weak, apathetic, unconscious * Seizure |
| Time to recovery | Up to 12 weeks | Determined by the number of days from admission to programmatic recovery among those who recovered |
| Failure | up to 12 weeks | Absence of weight gain, assessed at the 3rd consecutive visit; * Weight loss since admission to the program, assessed at the 1st visit after admission; * Loss of 5% of body weight compared to admission weight. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness | 12 weeks; 24 weeks | Cost-effectiveness, as defined by the incremental cost per child cured according to the program and per child cured sustainedly |
Countries
Burkina Faso
Contacts
Primary ContactHermann Biènou LANOU, MD., PhD.
Backup ContactSeni KOUANDA, MD., PhD
Outcome results
None listed