Does Administration of Probiotics During Infancy Increase the Caries Risk of a Child

February 21, 2012 updated by: Eva Soderling, University of Turku

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, 20520
        • University of Turku

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • B.lactis BB12 and L.rhamnosus GG in milk formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Caries occurence
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Oral microbial colonization
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Investigators

  • Study Director: Erika M Isolauri, Professor, University of Turku

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

August 26, 2011

First Submitted That Met QC Criteria

August 26, 2011

First Posted (Estimate)

August 29, 2011

Study Record Updates

Last Update Posted (Estimate)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 21, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Probiotics study7.4.2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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