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NCT01424852 Clinical Trial

Does Administration of Probiotics During Infancy Increase the Caries Risk of a Child

Dental Caries Clinical Trial

Official title:
Early Administration of Bifidobacterium Lactis BB-12 and the Caries Occurence of Children a 4 Years of Age

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01424852
Other study ID # Probiotics study7.4.2011
Secondary ID
Status Withdrawn
Phase N/A
First received August 26, 2011
Last updated February 21, 2012
Start date January 2012
Est. completion date December 2012

Study information
Verified date February 2012
Source University of Turku
Contact n/a
Is FDA regulated No
Health authority Finland: Ethics Committee
Study type Interventional

Clinical Trial Summary

Aim: to examine caries occurrence in children who ten years ago received a mixture of probiotics during infancy.

Hypothesis: the administration of probiotics during infancy has no effect on future dental health.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 9 Years to 12 Years
Eligibility Inclusion Criteria:

- Child participated in the probiotic milk intervention study in early 2000

- Child lives now within 100 km from Turku

Exclusion Criteria:

- Child has a chronic illness affecting dental health

- Child lives now outside 100 km from Turku

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Probiotics in infant milk formula
Probiotic infgant milk formula administered during the forst year of life

Locations
Country Name City State
Finland University of Turku Turku

Sponsors (1)
Lead Sponsor Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Caries occurence 10 years No
Secondary Oral microbial colonization 10 years No
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