Probiotics and Infections in Children Attending Day Care Centres - Tabular View

Tracking Information

First Received Date ^ICMJE

November 16, 2009

Last Updated Date

July 6, 2011

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT01014676 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Probiotics and Infections in Children Attending Day Care Centres

Official Title ^ICMJE

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Condition ^ICMJE

Respiratory Tract Infections
Gastrointestinal Diseases

Intervention ^ICMJE

Dietary Supplement: Probiotic
Other: Placebo

Study Arms

Active Comparator: Probiotic milk
Intervention: Dietary Supplement: Probiotic
Placebo Comparator: Standard milk
Intervention: Other: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

2 Years to 6 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland

Administrative Information

NCT Number ^ICMJE

NCT01014676

Other Study ID Numbers ^ICMJE

Valio-69

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

Valio Ltd

Collaborators ^ICMJE

Helsinki University

Investigators ^ICMJE

Principal Investigator:

Anne Pitkäranta, Professor

Helsinki University Central Hospital

Information Provided By

Valio Ltd

Verification Date

July 2011

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