No registrations found.
ID
Source
Brief title
Health condition
Infections
(Dutch: infecties)
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- 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)
Background summary
In this study the effect of a Growing up milk with added prebiotics and LCPUFA will be compared with the effect of a Growing up milk without prebiotics and LCPUFA on the occurrence of infections in healthy toddlers during a year.
Study objective
It is expected that drinking Growing up milk with added prebiotics and LCPUFA will results in a lower occurrence of infections in healthy toddlers compared to a Growing up milk without prebiotics and LCPUFA.
Study design
Visit 1: Screening
Visit 2: Baseline
Visit 3: Week 2
Visit 4: Week 14
Visit 5: Week 26
Visit 6: Week 38
Visit 7: Week 52
A run-in period between screening and baseline.
Several phone contacts between the visits during the study.
Intervention
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 for toddlers
The study will also include a reference group of toddlers who use cow’s milk.
P.O. box 7005
M. Huffelen, van
Wageningen 6700 CA
The Netherlands
+31 (0)317 467948
P.O. box 7005
M. Huffelen, van
Wageningen 6700 CA
The Netherlands
+31 (0)317 467948
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1391 |
| NTR-old | NTR1451 |
| CCMO | NL24606.072.08 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |