Prebiotic Effects in Healthy Toddlers
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.
| Condition(s) | Child Development, Diet, Healthy |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: 1. Child is healthy at the time of pre-examination 2. Child is aged between 10-36 months and attends a day care center for the duration of the intervention 3. Child attends a daycare center at the time of pre examination for at least 50%. 4. Child presents a normal defecation characteristic (according to Brussels Infant and Toddler Stool scale) 5. Weight for height z-score \>-2 and \<2 SD based on Flemish growth charts 6. Child and legal guardian are able and willing to follow the study instructions 7. Child is suitable for participation in the study according to the investigator/ study personnel 8. Informed written consent given by parent / legal guardian Exclusion Criteria: 1. No legal guardian's command of any local language 2. Child with any chronic disorder or dise |
| Ages | 10 Months to 36 Months |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Beneo-Institute |
| Locations | Brussels, Belgium |
| Start date | 2023-10-01 |
| NCT ID | NCT05783141 |
| Official listing | https://clinicaltrials.gov/study/NCT05783141 |