Viewing Study NCT02716935



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Study NCT ID: NCT02716935
Status: COMPLETED
Last Update Posted: 2020-06-11
First Post: 2016-02-01

Brief Title: Prebiotics and Microbiota Composition and Functionality in Rural Burkinabe Infants
Sponsor: University Ghent
Organization: University Ghent

Study Overview

Official Title: Effect of Supplementation With LNS Fortified With a Mixture of FOS and Inulin on Gut Microbiota Diversity and Functionality and Its Repercussion on Growth and Morbidity During Infancy in Rural Burkina Faso
Status: COMPLETED
Status Verified Date: 2020-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None