Probiotics and Infections in Children Attending Day Care Centres
This study has been completed.
Sponsor:
Valio Ltd
Collaborator:
Helsinki University
Information provided by:
Valio Ltd
ClinicalTrials.gov Identifier:
NCT01014676
First received: November 16, 2009
Last updated: July 6, 2011
Last verified: July 2011
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Purpose
The purpose of this study is to evaluate the effect of regular consumption of probiotic milk in preventing illnesses in Finnish children attending day care centres, and possible cost-benefits that could be associated with fewer illnesses.
| Condition | Intervention | Phase |
|---|---|---|
|
Respiratory Tract Infections Gastrointestinal Diseases |
Dietary Supplement: Probiotic Other: Placebo |
Phase 3 |
| Study Type: | Interventional |
Resource links provided by NLM:
Further study details as provided by Valio Ltd:
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Probiotic milk | Dietary Supplement: Probiotic |
| Placebo Comparator: Standard milk | Other: Placebo |
Eligibility| Ages Eligible for Study: | 2 Years to 6 Years |
| Genders Eligible for Study: | Both |
Criteria
Inclusion Criteria:
- Age 2 to 6 years in the beginning of the intervention
- Attendance at a day care centre participating in the study (5 days a week)
Exclusion Criteria:
- Milk allergy or lactose intolerance
- Congenital heart diseases that requires regular medication
- Malign diseases
- Cytostatic treatment
- Use of biological rheumatic medication
- Continuous microbial medication
- Regular use of oral corticosteroids (inhalable accepted)
- Diabetes
- Simultaneous participation in other clinical trials
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01014676
Locations
| Finland | |
| Clinical Life Sciences Inc. | |
| Kajaani and Oulu, Province of Oulu, Finland | |
Sponsors and Collaborators
Valio Ltd
Helsinki University
Investigators
| Principal Investigator: | Anne Pitkäranta, Professor | Helsinki University Central Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT01014676 History of Changes |
| Other Study ID Numbers: | Valio-69 |
| Study First Received: | November 16, 2009 |
| Last Updated: | July 6, 2011 |
| Health Authority: | Finland: Ethics Committee |
Keywords provided by Valio Ltd:
|
Costs and Cost Analysis |
Additional relevant MeSH terms:
|
Gastrointestinal Diseases Digestive System Diseases Respiratory Tract Infections Infection Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013