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Probiotics and Infections in Children Attending Day Care Centres

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01014676
Recruitment Status : Completed
First Posted : November 17, 2009
Last Update Posted : July 7, 2011
Helsinki University
Information provided by:
Valio Ltd

Brief Summary:
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 or disease Intervention/treatment Phase
Respiratory Tract Infections Gastrointestinal Diseases Dietary Supplement: Probiotic Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)

Arm Intervention/treatment
Active Comparator: Probiotic milk Dietary Supplement: Probiotic
Placebo Comparator: Standard milk Other: Placebo

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01014676

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Clinical Life Sciences Inc.
Kajaani and Oulu, Province of Oulu, Finland
Sponsors and Collaborators
Valio Ltd
Helsinki University
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Principal Investigator: Anne Pitkäranta, Professor Helsinki University Central Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT01014676     History of Changes
Other Study ID Numbers: Valio-69
First Posted: November 17, 2009    Key Record Dates
Last Update Posted: July 7, 2011
Last Verified: July 2011

Keywords provided by Valio Ltd:
Costs and Cost Analysis

Additional relevant MeSH terms:
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Respiratory Tract Infections
Gastrointestinal Diseases
Digestive System Diseases
Respiratory Tract Diseases