Microbiome-Directed Food for Sustained Recovery From Acute Malnutrition
NCT ID: NCT05586139
Last Updated: 2024-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
6200 participants
INTERVENTIONAL
2024-10-31
2026-12-31
Brief Summary
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* 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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Stratified by severity of malnutrition:
* 2 arms for Severe Acute malnutrition
* 2 arms for Moderate acute Malnutrition
TREATMENT
NONE
Study Groups
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Microbiome-directed food (MDF) - MAM
Each (MAM) child will receive a daily ration of MDF corresponding to his weight, for maximum 12 weeks
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.
Ready-to-use supplementary food (RUSF)
Each (MAM) child will receive a daily ration of MDF corresponding to his weight, for maximum 12 weeks
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.
Microbiome-directed food (MDF) - SAM
Each (SAM) child will receive a daily ration of MDF corresponding to his weight, for maximum 12 weeks of supplementation.
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.
Ready-to-use therapeutic food (RUTF)
Each (SAM) child will receive a daily ration of RUTF corresponding to his weight, for maximum 12 weeks of supplementation
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.
Interventions
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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.
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderate wasting: WHZ \< -2 and ≥ -3 or MUAC \< 125 mm and ≥ 115mm or - Severe wasting: WHZ \< -3 or MUAC \< 115 mm
Exclusion Criteria
* 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
6 Months
23 Months
ALL
No
Sponsors
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Ministry of Health, Burkina Faso
OTHER_GOV
Bill and Melinda Gates Foundation
OTHER
Institut de Recherche en Sciences de la Sante, Burkina Faso
OTHER_GOV
Responsible Party
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Hermann Lanou
Principal Investigator
Principal Investigators
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Seni KOUANDA, MD., PhD
Role: PRINCIPAL_INVESTIGATOR
Institut de Recherche en Sciences de la Santé, Burkina-Faso
Locations
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LANOU Hermann Bienou
Ouagadougou, Kadiogo, Burkina Faso
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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INV-016380
Identifier Type: -
Identifier Source: org_study_id
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