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

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.

Study Overview

• Status: Completed
• Conditions: Growth Retardation; Infant Morbidity
• Intervention / Treatment: Dietary supplement: Fortified lipid based nutrient supplement; Dietary supplement: lipid based nutrient supplement

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 Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Burkina Faso
  • Houet
    • Bobo-Dioulasso, Houet, Burkina Faso, 01 BP 545
      • IRSS/DRO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 5 months (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fortified lipid based nutrient supplement; lipid based nutrient supplement (Nutributter) fortified with fructo-oligosaccharides and inulin	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
ACTIVE_COMPARATOR: lipid based nutrient supplement; lipid based nutrient supplement (Nutributter)	Dietary supplement: lipid based nutrient supplement; Dietary Supplement: lipid based nutrient supplement (Nutributter) 6 months intervention: participant will take a daily dose of 20g supplement.
NO_INTERVENTION: non intervention group; This group will not be supplemented

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Stool consistency	Stool consistency will be recalled	Once every week during the first month of supplementation
Stool frequency per day	Stool frequency per day will be recalled.	6 months
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
Calprotectin concentration in stool	Concentration of calprotectin will be measured by ELISA	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	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	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	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	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	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	3 months and 6 months

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: Institut de Recherche en Sciences de la Sante, Burkina Faso; Nutriset

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (ACTUAL): April 24, 2018
• Study Completion (ACTUAL): November 1, 2019

Study Registration Dates

• First Submitted: February 1, 2016
• First Submitted That Met QC Criteria: March 22, 2016
• First Posted (ESTIMATE): March 23, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 8, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: University Ghent

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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)