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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This study has been withdrawn prior to enrollment.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:
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

August 26, 2011
February 21, 2012
January 2012
December 2012   (final data collection date for primary outcome measure)
Caries occurence [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01424852 on ClinicalTrials.gov Archive Site
Oral microbial colonization [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Does Administration of Probiotics During Infancy Increase the Caries Risk of a Child
Early Administration of Bifidobacterium Lactis BB-12 and the Caries Occurence of Children a 4 Years of Age

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Dental Caries
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
  • Active Comparator: Probiotics in milk formula
    B. lactis BB-12 and L. rhamnosus GG delivered in milk formula during the first year of infancy
    Intervention: Dietary Supplement: Probiotics in infant milk formula
  • Placebo Comparator: Control milk formula
    The children received milk formula with no probiotics
    Intervention: Dietary Supplement: Probiotics in infant milk formula
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
9 Years to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01424852
Probiotics study7.4.2011
Yes
Eva Soderling, University of Turku
University of Turku
Not Provided
Study Director: Erika M Isolauri, Professor University of Turku
University of Turku
February 2012

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