Probiotics and Infections in Children Attending Day Care Centres

This study has been completed.
Sponsor:
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
  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 April 23, 2014