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| Name | Class |
|---|---|
| Institut de Recherche en Sciences de la Sante, Burkina Faso | OTHER_GOV |
| Nutriset | INDUSTRY |
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The purpose of this study is to assess the effect of a mixture of prebiotics included in a food supplement on microbiota diversity and functionality, and to explore its subsequent effects on linear growth velocity and morbidity.
The central role of gut microbiota in immunity and nutritional homeostasis is now acknowledged, albeit not fully understood. Gut microbiota composition imbalances have been found in malnourished children, which were not restored by nutritional interventions as currently conducted. Therefore, the necessity to design more complete nutritional interventions that include gut health has been advised by expert committees.
Prebiotics are compound that selectively enhance the growth of beneficial gut bacteria. They have been recommended and used in infant formula and weaning cereals resulting in gut microbiota resembling that of breastfed infants in formula fed infants in developed countries. A healthy gut microbiota was shown to be associated with enhanced growth patterns and decreased morbidity in children in developed countries. Evidence of such outcome is lacking in developing countries, yet such results would be particularly valuable for children from these settings, living in rather poor sanitary conditions in an environment characterized with high infectious disease load, conditions that mostly explain the high prevalence of chronic malnutrition. This study aims to assess the effect of a 6 months' supplementation with a lipid based nutrient supplement fortified with fructo-oligosaccharides and inulin on microbiota diversity and functionality in rural Burkinabe infants, and to explore its subsequent effects on linear growth velocity and morbidity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fortified lipid based nutrient supplement | Experimental | lipid based nutrient supplement (Nutributter) fortified with fructo-oligosaccharides and inulin |
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| lipid based nutrient supplement | Active Comparator | lipid based nutrient supplement (Nutributter) |
|
| non intervention group | No Intervention | This group will not be supplemented |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fortified lipid based nutrient supplement | Dietary Supplement | 6 months intervention: participant will take a daily dose of 20g supplement. The product contains 3 g of a mixture (1:1) of inulin and fructan-oligosaccharide |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal microbiota range-weighted richness | Composition of fecal microbiota will be determined by Illumina sequencing from which range-weighted richness will be calculated | 6 months |
| Mean concentration of short-chain fatty acids in stool | Concentration of short-chain fatty acids (acetate, butyrate and propionate) will be measured by Gas Chromatography | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of digestive intolerance symptoms (flatulence, abdominal pain, regurgitation, vomiting, or diarrhea) | Digestive intolerance symptoms will be recalled. | once every week during the first month of supplementation |
| Stool consistency |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRSS/DRO | Bobo-Dioulasso | Houet | 01 BP 545 | Burkina Faso |
Upon publication of the main findings, data will be shared on a public repository and made publicly available on request as per recently published guidance and regulations (BMJ 2016;352:i255)
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| lipid based nutrient supplement | Dietary Supplement | Dietary Supplement: lipid based nutrient supplement (Nutributter) 6 months intervention: participant will take a daily dose of 20g supplement. |
|
Stool consistency will be recalled
| Once every week during the first month of supplementation |
| Stool frequency per day | Stool frequency per day will be recalled. | 6 months |
| Mean stool pH | Stool pH will be measured once a week with pH sticks by a study nurse | once every week during the first month of supplementation |
| Calprotectin concentration in stool | Concentration of calprotectin will be measured by ELISA | at inclusion, 3 months and 6months after inclusion |
| Infant linear growth velocity | Linear growth velocity will be determined using the difference between 2 length measures over the follow up time in months and expressed in millimeters/ month | once a month during 6 months |
| Infant ponderal growth velocity | Ponderal growth velocity will be determined using the difference between 2 weight measures over the follow up time in month and expressed in grams/ month. Infant's weight will be measured at inclusion and once a month during 6 months | once a month during 6 months |
| Cumulative morbidity | Cumulative morbidity of (malaria, gastro-intestinal tract infection, acute respiratory tract infection, acute otitis) will be assessed one a week by a study nurse | Starting from inclusion, weekly during a follow-up of 6 months |
| Infant's intestinal permeability | Intestinal permeability will be assessed using a mannitol-lactulose test | at inclusion, 3 months and 6 months after inclusion |
| Residual fecal microbiota range-weighted richness | Composition of fecal microbiota will be determined by Illumina sequencing, from which range-weighted richness will be calculated | 3 months and 6 months |
| Residual concentration of short-chain fatty acids in stool | Concentration of short chain fatty acids (acetate, butyrate and propionate) will be measured by Gas Chromatography | 3 months and 6 months |