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

NCT ID: NCT01424852

Last Updated: 2012-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotics in milk formula

B. lactis BB-12 and L. rhamnosus GG delivered in milk formula during the first year of infancy

Group Type ACTIVE_COMPARATOR

Probiotics in infant milk formula

Intervention Type DIETARY_SUPPLEMENT

Probiotic infgant milk formula administered during the forst year of life

Control milk formula

The children received milk formula with no probiotics

Group Type PLACEBO_COMPARATOR

Probiotics in infant milk formula

Intervention Type DIETARY_SUPPLEMENT

Probiotic infgant milk formula administered during the forst year of life

Interventions

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Probiotics in infant milk formula

Probiotic infgant milk formula administered during the forst year of life

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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B.lactis BB12 and L.rhamnosus GG in milk formula

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Turku

OTHER

Sponsor Role lead

Responsible Party

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Eva Soderling

Adjunct Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erika M Isolauri, Professor

Role: STUDY_DIRECTOR

University of Turku

Locations

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University of Turku

Turku, Finland, Finland

Site Status

Countries

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Finland

Other Identifiers

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Probiotics study7.4.2011

Identifier Type: -

Identifier Source: org_study_id

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