Prebiotics and Microbiota Composition and Functionality in Rural Burkinabe Infants

Growth Retardation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02716935
• Other study ID #: University Ghent
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: November 2019

Study information

• Verified date: June 2020
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: November 2019
• Est. primary completion date: April 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Weeks to 26 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Growth Retardation
• Infant Morbidity

Intervention

Dietary Supplement:
• Fortified lipid based nutrient 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
• lipid based nutrient supplement
Dietary Supplement: lipid based nutrient supplement (Nutributter) 6 months intervention: participant will take a daily dose of 20g supplement.

Locations

Country	Name	City	State
Burkina Faso	IRSS/DRO	Bobo-Dioulasso	Houet

Sponsors (3)

Lead Sponsor	Collaborator
University Ghent	Institut de Recherche en Sciences de la Sante, Burkina Faso, Nutriset

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	Stool consistency	Stool consistency will be recalled	Once every week during the first month of supplementation
Secondary	Stool frequency per day	Stool frequency per day will be recalled.	6 months
Secondary	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
Secondary	Calprotectin concentration in stool	Concentration of calprotectin will be measured by ELISA	at inclusion, 3 months and 6months after inclusion
Secondary	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
Secondary	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
Secondary	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
Secondary	Infant's intestinal permeability	Intestinal permeability will be assessed using a mannitol-lactulose test	at inclusion, 3 months and 6 months after inclusion
Secondary	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
Secondary	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