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This study has been withdrawn prior to enrollment.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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases

ClinicalTrials.gov processed this record on October 22, 2014