Clinical Trials Directory

Trials / Completed

CompletedNCT02716935

Prebiotics and Microbiota Composition and Functionality in Rural Burkinabe Infants

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
Phase
N/A
Study type
Interventional
Enrollment
153 (actual)
Sponsor
University Ghent · Academic / Other
Sex
All
Age
24 Weeks – 26 Weeks
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTFortified lipid based nutrient supplement6 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_SUPPLEMENTlipid based nutrient supplementDietary Supplement: lipid based nutrient supplement (Nutributter) 6 months intervention: participant will take a daily dose of 20g supplement.

Timeline

Start date
2016-03-01
Primary completion
2018-04-24
Completion
2019-11-01
First posted
2016-03-23
Last updated
2020-06-11

Locations

1 site across 1 country: Burkina Faso

Source: ClinicalTrials.gov record NCT02716935. Inclusion in this directory is not an endorsement.