Clinical trial NCT02716935: Prebiotics and Microbiota Composition and Functionality in Rural Burkinabe Infants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth Retardation
Infant Morbidity
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Institut de Recherche en Sciences de la Sante, Burkina Faso
name: Nutriset
First posted: 2016-03-23
Enrollment: 153
Sex: ALL
Minimum age (years): 24
Maximum age (years): 26
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* 6-6.5 month old infants
* Weight for height and height for age z-score above -2
* Permanent resident of the area and not intending to move for the next 6 months for more than a week
* No chronic antibiotic treatment
* Exempt of any current serious illness
* Still breastfed.

Exclusion Criteria:

* Moderate or severe malnutrition (weight for height or height for age z-score below -2)
* non-permanent residence in the study area,
* the presence of any congenital anomalies in the child or mental/physical disease of the mother that can interfere with child feeding
* a chronic antibiotic treatment i.e. more than 6 weeks treatment at the time of enrolment
* a history of allergy to a constituent of the supplement
* a serious current illness

Primary outcomes:
measure: Fecal microbiota range-weighted richness
timeFrame: 6 months
measure: Mean concentration of short-chain fatty acids in stool
timeFrame: 6 months
Secondary outcomes:
measure: Frequency of digestive intolerance symptoms (flatulence, abdominal pain, regurgitation, vomiting, or diarrhea)
timeFrame: once every week during the first month of supplementation
measure: Stool consistency
timeFrame: Once every week during the first month of supplementation
measure: Stool frequency per day
timeFrame: 6 months
measure: Mean stool pH
timeFrame: once every week during the first month of supplementation
measure: Calprotectin concentration in stool
timeFrame: at inclusion, 3 months and 6months after inclusion
measure: Infant linear growth velocity
timeFrame: once a month during 6 months
measure: Infant ponderal growth velocity
timeFrame: once a month during 6 months
measure: Cumulative morbidity
timeFrame: Starting from inclusion, weekly during a follow-up of 6 months
measure: Infant's intestinal permeability
timeFrame: at inclusion, 3 months and 6 months after inclusion
measure: Residual fecal microbiota range-weighted richness
timeFrame: 3 months and 6 months
measure: Residual concentration of short-chain fatty acids in stool
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: Bobo-Dioulasso
country: Burkina Faso
facility: IRSS/DRO
state: Houet
Study officials:
References: