An interventional study of Fortified lipid based nutrient supplement and lipid based nutrient supplement in Growth Retardation and Infant Morbidity, sponsored by University Ghent. Completed at 1 site in Burkina Faso. Open to participants aged 24 Weeks to 26 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-11.
Sponsored by University Ghent · Not applicable, Interventional, and Prevention
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.
University Ghent is the lead sponsor of 345 studies on the registry; 85 are open to participants now.
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Exclusion Criteria:
lipid based nutrient supplement (Nutributter) fortified with fructo-oligosaccharides and inulin
Dietary Supplement: Fortified lipid based nutrient supplement
lipid based nutrient supplement (Nutributter)
Dietary Supplement: lipid based nutrient supplement
This group will not be supplemented
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
Dietary Supplement: lipid based nutrient supplement (Nutributter) 6 months intervention: participant will take a daily dose of 20g supplement.
Fecal microbiota range-weighted richness
Composition of fecal microbiota will be determined by Illumina sequencing from which range-weighted richness will be calculated
Time frame: 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
Time frame: 6 months
Frequency of digestive intolerance symptoms (flatulence, abdominal pain, regurgitation, vomiting, or diarrhea)
Digestive intolerance symptoms will be recalled.
Time frame: once every week during the first month of supplementation
Stool consistency
Stool consistency will be recalled
Time frame: Once every week during the first month of supplementation
Stool frequency per day
Stool frequency per day will be recalled.
Time frame: 6 months
Mean stool pH
Stool pH will be measured once a week with pH sticks by a study nurse
Time frame: once every week during the first month of supplementation
Calprotectin concentration in stool
Concentration of calprotectin will be measured by ELISA
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 months and 6 months
Plan to share: Yes — 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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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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