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| ID | Type | Description | Link |
|---|---|---|---|
| FPC N° 2013-4025 | Other Grant/Funding Number | Ministère de l'Europe et des Affaires Etrangères |
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| Name | Class |
|---|---|
| Action Contre la Faim | OTHER |
| Centre de Recherches Médicales et Sanitaires CERMES Niger | UNKNOWN |
| Institut Pasteur de Madagascar | OTHER |
| Institut Pasteur de Bangui |
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The aim of this open-label randomized controlled trial conducted in four African countries (Madagascar, Niger, Central African Republic and Senegal) is to compare three strategies of renutrition for moderate acute malnutrition (MAM) in children based on modulation of the gut microbiota with enriched flours alone, enriched flours with prebiotics or enriched flours coupled with antibiotic treatment. Cognitive development of children (Senegal) will also be studied and compared.
The main objective of this study is to improve the nutrition strategy used to take in charge moderate acute malnutrition (MAM) which is the major milestone before severe malnutrition. This will be based on the modulation of the gut microbiota with adjunct product added to standard nutrition flours.
The purpose of the MALINEA study is to compare three management strategies for Moderate Acute Malnutrition (MAM) in children aged between 6 months and 2 years old on recovery defined by a weight/size gain at 3 months.
The 3 groups will be compared on several anthropometric measurements [Weight, length, Mid Upper Arm Circumference (MUAC)], clinical characteristics, adherence and tolerance to interventions between before and after a 3 months intervention Cognitive development of children (Senegal) will also be studied and compared, at inclusion, 3 months and 6 months after inclusion.
The investigators will also investigate the microbiomes of malnourished children at inclusion and at 3 and 6 months after inclusion to compare it to the ones of normonourished children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Fortified Blended Flour (in association with a single dose of Albendazole at inclusion for children older than 12 months). 200 grams / day for children between 6 and 11 months. 300 grams / day for children aged from 12 to 24 months old. |
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| Azythromycin | Active Comparator | Fortified Blended Flour (in association with a single dose of Albendazole at inclusion for children older than 12 months) associated to Azythromycin, 20mg/kgs/days during the three first days of the study. |
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| Prebiotic | Active Comparator | Fortified Blended Flour mixed with Inuline and fructo-oligosaccharides (Synergy1) 2g/day, given to the child through the whole intervention (in association with a single dose of Albendazole at inclusion for children older than 12 months) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azythromycin | Drug | Administration of azythromycin to the child at inclusion (3 days) 20 mgs/kgs/day : three days |
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| Measure | Description | Time Frame |
|---|---|---|
| Recovery at three month | Recovery at three months, defined by: Weight/Size Z-score ≥ -1.5 SD measured at 2 following consultations without hospitalization, transfer, death or lost to follow up | Three month |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive-motor development (Senegal) | Developmental Milestones Checklist II (DMC II) questionnaire to evaluate participating children cognitive and motor abilities. | Baseline, three, six and nine months after inclusion |
| Comparison of the Operational Taxonomic Unit composition of stool samples according to the nutritional status |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronan JAMBOU, PhD | Institut Pasteur | Principal Investigator |
| Muriel Vray, phD | Institut Pasteur | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Pasteur de bangui - Centre Nutritionnel de Gbangouma et Centre de Santé Saint-Joseph | Bangui | BP 923 | Central African Republic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30514364 | Derived | Vray M, Hedible BG, Adam P, Tondeur L, Manirazika A, Randremanana R, Mainassara H, Briend A, Artaud C, von Platen C, Altmann M, Jambou R. A multicenter, randomized controlled comparison of three renutrition strategies for the management of moderate acute malnutrition among children aged from 6 to 24 months (the MALINEA project). Trials. 2018 Dec 4;19(1):666. doi: 10.1186/s13063-018-3027-3. |
| Label | URL |
|---|---|
| GRET: French development NGO fighting poverty and inequalities, providing solutions for development \[150 projects per year in 30 countries\] | View source |
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| AMBIG |
| Institut Pasteur de Dakar | OTHER |
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| Inuline and fructo-oligosaccharides | Dietary Supplement | Administration of inuline and fructo-oligosaccharides (Synergy1) 2g/day, mixed with the fortified blend flour given to the child through the whole intervention. |
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| Albendazole | Drug | Administration of Albendazole at inclusion of the child : 200mgs, one administration |
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| Fortified blend flour | Dietary Supplement | Children from 6 to 11 months : 200 grams / day Children from 12 to 24 months : 300 grams / day Compostion of the fortified blend flour per 100 grams : either : Mil (whole grains): 58,56 g/100g, Soybeans (fat meal): 16,54g/100g Peanuts (roasted seeds): 8,75g/100g, Cane sugar: 7,35 g/100g Whole milk (Powder): 7,56g/100g, MSV MAM: 0,28g/100g, iodized salt :0,45g/100g, CaC03: 0,48g/100g,Amylase BAN: 0,03g/100g OR Corn (whole grains): 53,29g/100g, Soybeans (dry seeds): 17,82g/100g, Peanuts (roasted seeds): 9,00 g/100g, Cane sugar: 11,00 Whole milk (Powder): 5,00g/100g, Soybean Oil (Purified): 1,24g/100g, Peanut oil (Purified): 1,13g/100g, MSV MAM: 0,27g/100g, iodized salt: 0,53 g/100g, Ca3(PO4)2: 0,62g/100g, KCl: 0,09g/100g |
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Each sample will be ADN extracted using Quiagen technology 16S and 18S amplification will be conducted following Hughert et al. (2014) and Tang et al. (2015). PCR products will be sequenced using NGS Illumina plateform. Sequences will be analyzed using Mothur 1.37.6 software and Silva data base (https://www.arb-silva.de/browser). OTU (Operational Taxonomic Unit) composition will be determined for each sample. OTU composition of samples from well and malnourished children will be compared using mann whitney test, and shift in OTUs during renutrition will be analysed using survival analysis. |
| Baseline, three and six months after inclusion |
| Institut Pasteur de Madagascar - CRENAM Andohotapenaka et Centre de Santé Mitia | Antananarivo | 101 | Madagascar |
| Centre de santé intégré ACF de Tchake et d'Issawanne | Maradi | Niger |
| Institut Pasteur de Dakar - Poste de Santé Hamo V | Dakar | Guédiawaye | Senegal |
| Institut Pasteur: Private non-profit foundation whose mission is to prevent and treat diseases through research, teaching, and public health initiatives. | View source |
| Action contre la faim \[Action against hunger\] : International humanitarian organization providing communities with access to safe water and sustainable solutions to hunger. | View source |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D000900 | Anti-Bacterial Agents |
| C116580 | fructooligosaccharide |
| D056692 | Prebiotics |
| D015766 | Albendazole |
| D000977 | Antiparasitic Agents |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
| D011134 | Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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