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Probiotics and Infections in Children Attending Day Care Centres

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01014676
First Posted: November 17, 2009
Last Update Posted: July 7, 2011
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.
Collaborator:
Helsinki University
Information provided by:
Valio Ltd
  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

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

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
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
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 ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01014676     History of Changes
Other Study ID Numbers: Valio-69
First Submitted: November 16, 2009
First Posted: November 17, 2009
Last Update Posted: July 7, 2011
Last Verified: July 2011

Keywords provided by Valio Ltd:
Costs and Cost Analysis

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