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.
ID
Bron
Verkorte titel
Aandoening
Infections
(Dutch: infecties)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
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.
Publiek
P.O. box 7005
M. Huffelen, van
Wageningen 6700 CA
The Netherlands
+31 (0)317 467948
Wetenschappelijk
P.O. box 7005
M. Huffelen, van
Wageningen 6700 CA
The Netherlands
+31 (0)317 467948
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1391 |
| NTR-old | NTR1451 |
| CCMO | NL24606.072.08 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |