Microbiome-Directed Food for Sustained Recovery From Acute Malnutrition (MDF)

Efficacy of a Food Targeting the Microbiota for a Sustained Recovery of Children With Uncomplicated Acute Malnutrition

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 it aims to answer 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) and a locally available food (LAF) 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 randomly assigned to study groups. The supplementation will be done on daily basis according to the child's weight for a maximum of 12 weeks, at which point the recovery assessment is done. Each child will be subsequently followed up to 24 weeks for 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

Individually randomized and controlled trial, Stratified by severity of malnutrition: 2 arms for Severe Acute malnutrition 3 arms for Moderate acute Malnutrition

Each (MAM) child will receive a daily ration of MDF corresponding to his weight, for maximum 12 weeks of supplementation

Each (MAM) child will receive a daily ration of MDF corresponding to his weight, for maximum 12 weeks of supplementation

Each (MAM) child will receive a basket of food ingredients to prepare a complementary food at home. The quantity of ingredients is based on child's weight. The food is given a maximum duration of 12 weeks.

Each (SAM) child will receive a daily ration of MDF corresponding to his weight, for maximum 12 weeks of supplementation.

Each (SAM) child will receive a daily ration of RUTF corresponding to his weight, for maximum 12 weeks of supplementation

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 MAM child will consume a food made of locally available ingredients 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.

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

Children who failed to attain a weight-for-height (WHZ) ≥ - 2 z-score or mid-upper arm circumference (MUAC) ≥ 125 mm

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

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.

Cost-effectiveness, as defined by the incremental cost per child cured according to the program and per child cured sustainedly

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