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

Overview

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 supplement Microbiome-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 supplement Ready-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 supplement Microbiome-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 supplement Ready-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.

Primary outcome measures

• Programmatic recovery defined by Weight-for-height (WHZ) ≥ - 2 z-score or mid-upper arm circumference (MUAC) ≥ 125 mm [Time frame: 12th weeks from admission to the supplementation program]
• Sustained recovery defined by WHZ ≥ - 2 z-score or MUAC ≥ 125 mm [Time frame: 24 weeks from admission to the supplementation program]

Secondary outcome measures (8)

• Mean change in Weight-for-height (WHZ) z-score [Time frame: 12 weeks from admission to the supplementation program]
• Mean change in Weight-for-age (WAZ) z-score [Time frame: 12 weeks from admission to the supplementation program]
• Mean change in Height-for-age (HAZ) z-score [Time frame: 12 weeks from admission to the supplementation program]
• Time to recovery [Time frame: Up to 12 weeks]
• Dropouts [Time frame: 12 weeks]
• Non-response defined by WHZ < -2 z-score, or a MUAC < 125 mm [Time frame: 12 weeks]
• Complications [Time frame: up to 12 weeks]
• Failure [Time frame: up to 12 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Burkina Faso · 1 center

• LANOU Hermann Bienou — Ouagadougou

Publications

• Lanou HB, Some JW, Koumbem MAA, Kouanda S. Microbiome-directed food to promote sustained recovery in children with uncomplicated acute malnutrition: protocol for a randomized controlled trial in Burkina Faso. BMC Nutr. 2025 May 13;11(1):92. doi: 10.1186/s40795-025-01045-x. PMID 40361242

Identifiers

NCT: NCT05586139 · INV-016380

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗