Growth Retardation, Infant Morbidity
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTFortified 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
DIETARY_SUPPLEMENTlipid based nutrient supplement
Dietary Supplement: lipid based nutrient supplement (Nutributter) 6 months intervention: participant will take a daily dose of 20g supplement.
Sponsors
Institut de Recherche en Sciences de la Sante, Burkina Faso
Nutriset
University Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
24 Weeks to 26 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fecal microbiota range-weighted richness | 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 | 6 months | Concentration of short-chain fatty acids (acetate, butyrate and propionate) will be measured by Gas Chromatography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool frequency per day | 6 months | Stool frequency per day will be recalled. |
| Mean stool pH | 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 | at inclusion, 3 months and 6months after inclusion | Concentration of calprotectin will be measured by ELISA |
| Infant linear growth velocity | 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 |
| Frequency of digestive intolerance symptoms (flatulence, abdominal pain, regurgitation, vomiting, or diarrhea) | once every week during the first month of supplementation | Digestive intolerance symptoms will be recalled. |
| Cumulative morbidity | 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 | 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 | 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 | 3 months and 6 months | Concentration of short chain fatty acids (acetate, butyrate and propionate) will be measured by Gas Chromatography |
| Infant ponderal growth velocity | 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 |
| Stool consistency | Once every week during the first month of supplementation | Stool consistency will be recalled |
Countries
Burkina Faso
Outcome results
None listed