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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This study has been withdrawn prior to enrollment.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
History of Changes
  Purpose

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.


Condition Intervention
Dental Caries
 Dietary Supplement: Probiotics in infant milk formula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Early Administration of Bifidobacterium Lactis BB-12 and the Caries Occurence of Children a 4 Years of Age

Resource links provided by NLM:

MedlinePlus related topics: Tooth Decay
U.S. FDA Resources

Further study details as provided by University of Turku:

Primary Outcome Measures:
  • Caries occurence [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Oral microbial colonization [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Probiotics in milk formula
B. lactis BB-12 and L. rhamnosus GG delivered in milk formula during the first year of infancy
 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
Placebo Comparator: Control milk formula
The children received milk formula with no probiotics
 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

  Eligibility

Ages Eligible for Study:   9 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424852

Locations
Finland
University of Turku
Turku, Finland, 20520
Sponsors and Collaborators
University of Turku
Investigators
Study Director: Erika M Isolauri, Professor University of Turku
  More Information

No publications provided

Responsible Party: Eva Soderling, Adjunct Professor, University of Turku
ClinicalTrials.gov Identifier: NCT01424852     History of Changes
Other Study ID Numbers: Probiotics study7.4.2011
Study First Received: August 26, 2011
Last Updated: February 21, 2012
Health Authority: Finland: Ethics Committee

Keywords provided by University of Turku:
Probiotics
Caries
Oral flora

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 16, 2013