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Completed

NCT Number: NCT02716935

Prebiotics and Microbiota Composition and Functionality in Rural Burkinabe Infants

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.

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Key information

Conditions

Growth Retardation Infant Morbidity

Age range

24 week–26 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRSS/DRO

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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.

  2. Stool consistency

    Time frame: Once every week during the first month of supplementation

    Stool consistency will be recalled

  3. Stool frequency per day

    Time frame: 6 months

    Stool frequency per day will be recalled.

  4. 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

  5. Calprotectin concentration in stool

    Time frame: at inclusion, 3 months and 6months after inclusion

    Concentration of calprotectin will be measured by ELISA

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • Institut de Recherche en Sciences de la Sante, Burkina Faso
  • Nutriset

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Mar 23, 2016
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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