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Trial record 1 of 1 for:    NCT02716935
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Prebiotics and Microbiota Composition and Functionality in Rural Burkinabe Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by University Ghent
Sponsor:
Collaborators:
IRSS/DRO, Burkina Faso
Nutriset SAS, France
Information provided by (Responsible Party):
University Ghent
ClinicalTrials.gov Identifier:
NCT02716935
First received: February 1, 2016
Last updated: March 23, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention
Growth Retardation
Infant Morbidity
Dietary Supplement: Fortified lipid based nutrient supplement
Dietary Supplement: lipid based nutrient supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by University Ghent:

Primary Outcome Measures:
  • Fecal microbiota range-weighted richness [ Time Frame: 6 months ]
    Composition of fecal microbiota will be determined by Illumina sequencing from which range-weighted richness will be calculated

  • Mean concentration of short-chain fatty acids in stool [ Time Frame: 6 months ]
    Concentration of short-chain fatty acids (acetate, butyrate and propionate) will be measured by Gas Chromatography


Secondary Outcome Measures:
  • Frequency of digestive intolerance symptoms (flatulence, abdominal pain, regurgitation, vomiting, or diarrhea) [ Time Frame: once every week during the first month of supplementation ]
    Digestive intolerance symptoms will be recalled.

  • Stool consistency [ Time Frame: Once every week during the first month of supplementation ]
    Stool consistency will be recalled

  • Stool frequency per day [ Time Frame: 6 months ]
    Stool frequency per day will be recalled.

  • Mean stool pH [ Time Frame: once every week during the first month of supplementation ]
    Stool pH will be measured once a week with pH sticks by a study nurse

  • Calprotectin concentration in stool [ Time Frame: at inclusion, 3 months and 6months after inclusion ]
    Concentration of calprotectin will be measured by ELISA

  • Infant linear growth velocity [ Time Frame: once a month during 6 months ]
    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

  • Infant ponderal growth velocity [ Time Frame: once a month during 6 months ]
    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

  • Cumulative morbidity [ Time Frame: Starting from inclusion, weekly during a follow-up of 6 months ]
    Cumulative morbidity of (malaria, gastro-intestinal tract infection, acute respiratory tract infection, acute otitis) will be assessed one a week by a study nurse

  • Infant's intestinal permeability [ Time Frame: at inclusion, 3 months and 6 months after inclusion ]
    Intestinal permeability will be assessed using a mannitol-lactulose test

  • Residual fecal microbiota range-weighted richness [ Time Frame: 3 months and 6 months ]
    Composition of fecal microbiota will be determined by Illumina sequencing, from which range-weighted richness will be calculated

  • Residual concentration of short-chain fatty acids in stool [ Time Frame: 3 months and 6 months ]
    Concentration of short chain fatty acids (acetate, butyrate and propionate) will be measured by Gas Chromatography


Estimated Enrollment: 153
Study Start Date: March 2016
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   24 Weeks to 26 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02716935

Contacts
Contact: Patrick Kolsteren, MD, PhD +32 (0) 9 264 9377 Patrick.Kolsteren@ugent.be
Contact: Laeticia Céline Toe, B, MD, MSc +32 9 264 93 77 cellaety@yahoo.fr

Locations
Burkina Faso
IRSS/DRO Recruiting
Bobo-Dioulasso, Houet, Burkina Faso, 01 BP 545
Contact: Laeticia Toe, MD    +226 71 00 72 72    cellaety@yahoo.fr   
Contact: Jean-Bosco Ouedraogo, MD, PhD    +226 70 35 46 80    jbouedraogo@gmail.com   
Sponsors and Collaborators
University Ghent
IRSS/DRO, Burkina Faso
Nutriset SAS, France
  More Information

Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT02716935     History of Changes
Other Study ID Numbers: University Ghent
Study First Received: February 1, 2016
Last Updated: March 23, 2016
Individual Participant Data  
Plan to Share IPD: Yes
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)

ClinicalTrials.gov processed this record on March 29, 2017