Overview
The aim of this study is to demonstrate that a dietary supplementation with a novel prebiotic combination is safe, well tolerated and able to improve overall health of toddlers.
Description
The fermentation of a novel prebiotic combination leads to a modulation of the gut microbiota composition, in particular to a growth stimulation of bifidobacteria, and the production of organic acids like lactate and short-chain fatty acids (SCFA).The efficacy of the prebiotic combination to improve toddler's digestive function will be addressed. The overall health will be assessed as a measure of reduced number of febrile days resulting in less days of absenteeism from daycare centers.
Eligibility
Inclusion Criteria:
- Child is healthy at the time of pre-examination
- Child is aged between 10-36 months and attends a day care center for the duration of the intervention
- Child attends a daycare center at the time of pre examination for at least 50%.
- Child presents a normal defecation characteristic (according to Brussels Infant and Toddler Stool scale)
- Weight for height z-score >-2 and <2 SD based on Flemish growth charts
- Child and legal guardian are able and willing to follow the study instructions
- Child is suitable for participation in the study according to the investigator/ study personnel
- Informed written consent given by parent / legal guardian
Exclusion Criteria:
- No legal guardian's command of any local language
- Child with any chronic disorder or disease, e.g., defecation disorders (incl. Hirschsprung and celiac disease) metabolic or renal abnormalities as well as mental or psychomotor retardation (incl. child´s mental delay and hypotonia)
- Child is suffering from congenital or acquired immunodeficiency
- Food allergies or intolerances
- Child is currently breast-fed more than once daily
- Use of drugs (e.g. antibiotics) influencing gastrointestinal function (6 weeks before intervention)
- Use of laxatives (4 weeks before intervention) as well as probiotic and prebiotic food supplements. Follow-on formula with L. Reuteri and/or GOS/FOS/HMO is allowed.
- Child is suffering from an infection at the time of pre examination or previous 7 days
- Child is currently involved or will be involved in another clinical or food study
- Child is not suitable for participation in the study according to the study personnel´s opinion