Back to resultsProbiotics and Infections in Children Attending Day Care Centres
Primary Purpose
Respiratory Tract Infections, Gastrointestinal Diseases
Status
Completed
Phase
Phase 3
Locations
Finland
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
About this trial
This is an interventional trial for Respiratory Tract Infections focused on measuring Costs and Cost Analysis
Eligibility 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
Sites / Locations
- Clinical Life Sciences Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Probiotic milk
Standard milk
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01014676
First Posted
November 16, 2009
Last Updated
July 6, 2011
Sponsor
Valio Ltd
Collaborators
University of Helsinki
1. Study Identification
Unique Protocol Identification Number
NCT01014676
Brief Title
Probiotics and Infections in Children Attending Day Care Centres
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Valio Ltd
Collaborators
University of Helsinki
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Tract Infections, Gastrointestinal Diseases
Keywords
Costs and Cost Analysis
7. Study Design
Study Phase
Phase 3
8. Arms, Groups, and Interventions
Arm Title
Probiotic milk
Arm Type
Active Comparator
Arm Title
Standard milk
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Type
Other
Intervention Name(s)
Placebo
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Pitkäranta, Professor
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Life Sciences Inc.
City
Kajaani and Oulu
State/Province
Province of Oulu
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
27111772
Citation
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.
Results Reference
derived
Learn more about this trial
Probiotics and Infections in Children Attending Day Care Centres
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