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| Name | Class |
|---|---|
| Ministry of Health, Burkina Faso | OTHER_GOV |
| Bill and Melinda Gates Foundation | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microbiome-directed food (MDF) - MAM | Experimental | Each (MAM) child will receive a daily ration of MDF corresponding to his weight, for maximum 12 weeks |
|
| Ready-to-use supplementary food (RUSF) | Active Comparator | Each (MAM) child will receive a daily ration of MDF corresponding to his weight, for maximum 12 weeks |
|
| Microbiome-directed food (MDF) - SAM | Experimental | Each (SAM) child will receive a daily ration of MDF corresponding to his weight, for maximum 12 weeks of supplementation. |
|
| Ready-to-use therapeutic food (RUTF) | Active Comparator | Each (SAM) child will receive a daily ration of RUTF corresponding to his weight, for maximum 12 weeks of supplementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microbiome-directed food - MAM | Dietary Supplement | Each MAM child will be supplemented with MDF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12th weeks from admission to the supplementation program |
| Sustained recovery defined by WHZ ≥ - 2 z-score or MUAC ≥ 125 mm | Children who sustain recovery (WHZ ≥ - 2 z-score or MUAC ≥ 125 mm) up to 24 weeks | 24 weeks from admission to the supplementation program |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Weight-for-height (WHZ) z-score | (WHZ z-score at admission) - (WHZ z-score at 12 weeks) | 12 weeks from admission to the supplementation program |
| Mean change in Weight-for-age (WAZ) z-score |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness | Cost-effectiveness, as defined by the incremental cost per child cured according to the program and per child cured sustainedly | 12 weeks; 24 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hermann Biènou LANOU, MD., PhD. | Contact | +226 66557580 | hlanou@yahoo.ca | |
| Seni KOUANDA, MD., PhD | Contact | +226 70261462 | senikouanda@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Seni KOUANDA, MD., PhD | Institut de Recherche en Sciences de la Santé, Burkina-Faso | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LANOU Hermann Bienou | Ouagadougou | Kadiogo | Burkina Faso |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40361242 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 8, 2022 | Oct 14, 2022 |
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Individually randomized and controlled trial,
Stratified by severity of malnutrition:
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|
| Ready-to-use supplementary food (RUSF) | Dietary Supplement | 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 | Dietary Supplement | 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) | Dietary Supplement | Each SAM child will be supplemented with RUTF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks. |
|
|
(WAZ z-score at admission) - (WAZ z-score at 12 weeks)
| 12 weeks from admission to the supplementation program |
| Mean change in Height-for-age (HAZ) z-score | (HAZ z-score at admission) - (HAZ z-score at 12 weeks) | 12 weeks from admission to the supplementation program |
| Time to recovery | Determined by the number of days from admission to programmatic recovery among those who recovered | Up to 12 weeks |
| Dropouts | Lost to follow up | 12 weeks |
| Non-response defined by WHZ < -2 z-score, or a MUAC < 125 mm | Children who failed to attain a weight-for-height (WHZ) ≥ - 2 z-score or mid-upper arm circumference (MUAC) ≥ 125 mm | 12 weeks |
| Complications |
| up to 12 weeks |
| Failure | Absence of weight gain, assessed at the 3rd consecutive visit;
| up to 12 weeks |
| SAP_000.pdf |
| ID | Term |
|---|---|
| C074705 | milk-derived factor |
| D012436 | S-Adenosylmethionine |
| ID | Term |
|---|---|
| D008715 | Methionine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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