Infections (Dutch: infecties)
Conditions
Interventions
Duration intervention: 1 year (+ 4 weeks run-in)
Intervention group: a Growing up milk with added prebiotics and LCPUFA for toddlers.
Control group: a Growing up milk without prebiotics and LCPUFA
Sponsors
Danone Research B.V. (formerly known as Numico Research B.V.)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy subjects between 11 and 29 months of age 2. Attending a daycare centre for at least 2 times per week 3. Expected study product intake of 400 – 750 ml per day 4. Written informed consent from the parents
Exclusion criteria
Exclusion criteria: 1. Subjects who were never ill in the last 6 months 2. Atopic dermatitis according to the Hannifin criteria 3. Disorders requiring a special diet 4. Any relevant congenital abnormality, chromosomal disorder or severe disease 5. Pre-existing pathology of severe respiratory or gastrointestinal diseases 6. Diagnosed immunodeficiency disease 7. Current use of anti-regurgitation, anti-reflux or laxative medication 8. Expected inability to adhere to protocol instructions 9. Participation in any other study involving investigational or marketed products concomitantly 10. Currently being breastfed 11. Current use of immunomodulators 12. Current use of prophylactic prescribed antibiotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number and duration of episodes (in days) of upper respiratory tract infections and/ or gastrointestinal infections based on a combination of subject illness’ symptoms reported by parents. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Parents’ reported symptoms of illness and/ or allergy - Use of medication - Visits to a physician - Illnesses diagnosed by a physician - Hospitalization - Daycare absence and parents’ absence of work due to illness of the toddler - Anthropometrics - Gastrointestinal tolerance - Dietary intake (in a subgroup) | — |
Contacts
Public ContactM. Huffelen, van
Danone Research P.O. box 7005
Outcome results
None listed