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A study on the effect of a Growing up milk on the occurrence of infections in toddlers


- candidate number4104
- NTR NumberNTR1451
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-sep-2008
- Secondary IDsNL24606.072.08 ABR dossiernummer
- Public TitleA study on the effect of a Growing up milk on the occurrence of infections in toddlers
- Scientific TitleA randomized, double blind, controlled study on the effect of a Growing up milk on the occurrence of infections in toddlers
- ACRONYMGIANT (Growing up milk, Infections and Toddlers)
- hypothesisIt 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.
- Healt Condition(s) or Problem(s) studiedPrebiotics, Infection
- Inclusion criteria1. 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 criteria1. 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2008
- planned closingdate31-mrt-2010
- Target number of participants650
- InterventionsDuration 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.
- Primary outcomeThe 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)
- TimepointsVisit 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.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES M. Huffelen, van
- CONTACT for SCIENTIFIC QUERIES L. Dumon
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Danone Research B.V.
- PublicationsN/A
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD22-sep-2008 - 1-okt-2008


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