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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
November 16, 2009
November 17, 2009
July 7, 2011
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Complete list of historical versions of study NCT01014676 on ClinicalTrials.gov Archive Site
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Probiotics and Infections in Children Attending Day Care Centres
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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.
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Interventional
Phase 3
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  • Respiratory Tract Infections
  • Gastrointestinal Diseases
  • Dietary Supplement: Probiotic
  • Other: Placebo
  • Active Comparator: Probiotic milk
    Intervention: Dietary Supplement: Probiotic
  • Placebo Comparator: Standard milk
    Intervention: Other: Placebo
Korpela K, Salonen A, Virta LJ, Kumpu M, Kekkonen RA, de Vos WM. Lactobacillus rhamnosus GG Intake Modifies Preschool Children's Intestinal Microbiota, Alleviates Penicillin-Associated Changes, and Reduces Antibiotic Use. PLoS One. 2016 Apr 25;11(4):e0154012. doi: 10.1371/journal.pone.0154012. eCollection 2016.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Sexes Eligible for Study: All
2 Years to 6 Years   (Child)
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Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT01014676
Valio-69
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Valio Ltd
Helsinki University
Principal Investigator: Anne Pitkäranta, Professor Helsinki University Central Hospital
Valio Ltd
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP