Back to resultsDoes Administration of Probiotics During Infancy Increase the Caries Risk of a Child
Primary Purpose
Dental Caries
Status
Withdrawn
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Probiotics in infant milk formula
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries focused on measuring Probiotics, Caries, Oral flora
Eligibility Criteria
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
Sites / Locations
- University of Turku
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Probiotics in milk formula
Control milk formula
Arm Description
B. lactis BB-12 and L. rhamnosus GG delivered in milk formula during the first year of infancy
The children received milk formula with no probiotics
Outcomes
Primary Outcome Measures
Caries occurence
Secondary Outcome Measures
Oral microbial colonization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01424852
Brief Title
Does Administration of Probiotics During Infancy Increase the Caries Risk of a Child
Official Title
Early Administration of Bifidobacterium Lactis BB-12 and the Caries Occurence of Children a 4 Years of Age
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Too few of the invited subjects wanted to participate
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turku
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Probiotics, Caries, Oral flora
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotics in milk formula
Arm Type
Active Comparator
Arm Description
B. lactis BB-12 and L. rhamnosus GG delivered in milk formula during the first year of infancy
Arm Title
Control milk formula
Arm Type
Placebo Comparator
Arm Description
The children received milk formula with no probiotics
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics in infant milk formula
Other Intervention Name(s)
B.lactis BB12 and L.rhamnosus GG in milk formula
Intervention Description
Probiotic infgant milk formula administered during the forst year of life
Primary Outcome Measure Information:
Title
Caries occurence
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Oral microbial colonization
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erika M Isolauri, Professor
Organizational Affiliation
University of Turku
Official's Role
Study Director
Facility Information:
Facility Name
University of Turku
City
Turku
ZIP/Postal Code
20520
Country
Finland
12. IPD Sharing Statement
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Does Administration of Probiotics During Infancy Increase the Caries Risk of a Child
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