Clinical trial NCT05586139: Microbiome-Directed Food for Sustained Recovery From Acute Malnutrition
Official title: Efficacy of a Food Targeting the Microbiota for a Sustained Recovery of Children With Uncomplicated Acute Malnutrition
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Malnutrition With no Complications
Lead sponsor: Institut de Recherche en Sciences de la Sante, Burkina Faso
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, Burkina Faso
name: Bill and Melinda Gates Foundation
First posted: 2022-10-19
Enrollment: 6200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Programmatic recovery defined by Weight-for-height (WHZ) ≥ - 2 z-score or mid-upper arm circumference (MUAC) ≥ 125 mm
timeFrame: 12th weeks from admission to the supplementation program
measure: Sustained recovery defined by WHZ ≥ - 2 z-score or MUAC ≥ 125 mm
timeFrame: 24 weeks from admission to the supplementation program
Secondary outcomes:
measure: Mean change in Weight-for-height (WHZ) z-score
timeFrame: 12 weeks from admission to the supplementation program
measure: Mean change in Weight-for-age (WAZ) z-score
timeFrame: 12 weeks from admission to the supplementation program
measure: Mean change in Height-for-age (HAZ) z-score
timeFrame: 12 weeks from admission to the supplementation program
measure: Time to recovery
timeFrame: Up to 12 weeks
measure: Dropouts
timeFrame: 12 weeks
measure: Non-response defined by WHZ < -2 z-score, or a MUAC < 125 mm
timeFrame: 12 weeks
measure: Complications
timeFrame: up to 12 weeks
measure: Failure
timeFrame: up to 12 weeks
Other outcomes:
measure: Cost-effectiveness
timeFrame: 12 weeks; 24 weeks
Locations:
city: Ouagadougou
country: Burkina Faso
facility: LANOU Hermann Bienou
state: Kadiogo
Study officials:
affiliation: Institut de Recherche en Sciences de la Santé, Burkina-Faso
name: Seni KOUANDA, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References: