Prebiotics and Microbiota Composition and Functionality in Rural Burkinabe Infants

NCT02716935 | Completed

• 1 other identifier: University Ghent
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Growth Retardation; Infant Morbidity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Frequency of digestive intolerance symptoms (flatulence, abdominal pain, regurgitation, vomiting, or diarrhea)

  once every week during the first month of supplementation

• Stool consistency

  Once every week during the first month of supplementation

• Stool frequency per day

  6 months

• Mean stool pH

  once every week during the first month of supplementation

• Calprotectin concentration in stool

  at inclusion, 3 months and 6months after inclusion

Study Arms (3)

Fortified lipid based nutrient supplement

EXPERIMENTAL

lipid based nutrient supplement (Nutributter) fortified with fructo-oligosaccharides and inulin

Dietary Supplement: Fortified lipid based nutrient supplement

lipid based nutrient supplement

ACTIVE COMPARATOR

lipid based nutrient supplement (Nutributter)

Dietary Supplement: lipid based nutrient supplement

non intervention group

NO INTERVENTION

This group will not be supplemented

Interventions

Fortified lipid based nutrient supplement DIETARY_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

Fortified lipid based nutrient supplement

lipid based nutrient supplement DIETARY_SUPPLEMENT

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

lipid based nutrient supplement

Eligibility Criteria

• Age: 24 Weeks - 26 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead
• Institut de Recherche en Sciences de la Sante, Burkina Faso: collaborator
• Nutriset: collaborator

Study Sites (1)

IRSS/DRO

Bobo-Dioulasso, Houet, 01 BP 545, Burkina Faso

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: March 23, 2016
• Study Start: March 1, 2016
• Primary Completion: April 24, 2018
• Study Completion: November 1, 2019
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share

Locations

BU (1)