Does Administration of Probiotics During Infancy Increase the Caries Risk of a Child
This study has been withdrawn prior to enrollment.
(Too few of the invited subjects wanted to participate)
Sponsor:
University of Turku
Information provided by (Responsible Party):
Eva Soderling, University of Turku
ClinicalTrials.gov Identifier:
NCT01424852
First received: August 26, 2011
Last updated: February 21, 2012
Last verified: February 2012
| Tracking Information | |||||
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| First Received Date ICMJE | August 26, 2011 | ||||
| Last Updated Date | February 21, 2012 | ||||
| Start Date ICMJE | January 2012 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Caries occurence [ Time Frame: 10 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01424852 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Oral microbial colonization [ Time Frame: 10 years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Does Administration of Probiotics During Infancy Increase the Caries Risk of a Child | ||||
| Official Title ICMJE | Early Administration of Bifidobacterium Lactis BB-12 and the Caries Occurence of Children a 4 Years of Age | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Dental Caries | ||||
| Intervention ICMJE | Dietary Supplement: Probiotics in infant milk formula
Probiotic infgant milk formula administered during the forst year of life
Other Name: B.lactis BB12 and L.rhamnosus GG in milk formula |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Enrollment ICMJE | 0 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 9 Years to 12 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Finland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01424852 | ||||
| Other Study ID Numbers ICMJE | Probiotics study7.4.2011 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Eva Soderling, University of Turku | ||||
| Study Sponsor ICMJE | University of Turku | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Turku | ||||
| Verification Date | February 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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