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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6,200
Each MAM child will be supplemented with MDF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.
Each MAM child will be supplemented with RUSF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.
Each SAM child will be supplemented with MDF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.
Each SAM child will be supplemented with RUTF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.
LANOU Hermann Bienou
Ouagadougou, Kadiogo, Burkina Faso
Programmatic recovery defined by Weight-for-height (WHZ) ≥ - 2 z-score or mid-upper arm circumference (MUAC) ≥ 125 mm
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
Time frame: 12th weeks from admission to the supplementation program
Sustained recovery defined by WHZ ≥ - 2 z-score or MUAC ≥ 125 mm
Children who sustain recovery (WHZ ≥ - 2 z-score or MUAC ≥ 125 mm) up to 24 weeks
Time frame: 24 weeks from admission to the supplementation program
Mean change in Weight-for-height (WHZ) z-score
(WHZ z-score at admission) - (WHZ z-score at 12 weeks)
Time frame: 12 weeks from admission to the supplementation program
Mean change in Weight-for-age (WAZ) z-score
(WAZ z-score at admission) - (WAZ z-score at 12 weeks)
Time frame: 12 weeks from admission to the supplementation program
Mean change in Height-for-age (HAZ) z-score
(HAZ z-score at admission) - (HAZ z-score at 12 weeks)
Time frame: 12 weeks from admission to the supplementation program
Time to recovery
Determined by the number of days from admission to programmatic recovery among those who recovered
Time frame: Up to 12 weeks
Dropouts
Lost to follow up
Time frame: 12 weeks
Non-response defined by WHZ < -2 z-score, or a MUAC < 125 mm
Children who failed to attain a weight-for-height (WHZ) ≥ - 2 z-score or mid-upper arm circumference (MUAC) ≥ 125 mm
Time frame: 12 weeks
Complications
* 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 frame: up to 12 weeks
Failure
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.
Time frame: up to 12 weeks
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