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

Institut de Recherche en Sciences de la Sante, Burkina Faso

Status: Not yet enrolling

Conditions: Acute Malnutrition With no Complications

Treatments: Dietary Supplement: Microbiome-directed food (MDF) - SAM; Dietary Supplement: Ready-to-use therapeutic food (RUTF); Dietary Supplement: Ready-to-use supplementary food (RUSF); Dietary Supplement: Microbiome-directed food - MAM

Study type: Interventional

Funder types: Other

Identifiers

NCT05586139

INV-016380

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,200 estimated patients

Sex: All

Ages: 6 to 23 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6,200 participants in 4 patient groups

Microbiome-directed food (MDF) - MAM

Experimental group

Description:

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

Treatment:

Dietary Supplement: Microbiome-directed food - MAM

Ready-to-use supplementary food (RUSF)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Ready-to-use supplementary food (RUSF)

Microbiome-directed food (MDF) - SAM

Experimental group

Description:

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

Treatment:

Dietary Supplement: Microbiome-directed food (MDF) - SAM

Ready-to-use therapeutic food (RUTF)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Ready-to-use therapeutic food (RUTF)