NCT01424852

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 22, 2012

Status Verified

February 1, 2012

Enrollment Period

11 months

First QC Date

August 26, 2011

Last Update Submit

February 21, 2012

Conditions

Dental Caries

Keywords

ProbioticsCariesOral flora

Outcome Measures

Primary Outcomes (1)

  • Caries occurence

    10 years

Secondary Outcomes (1)

  • Oral microbial colonization

    10 years

Study Arms (2)

Probiotics in milk formula

ACTIVE COMPARATOR

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

Control milk formula

PLACEBO COMPARATOR

The children received milk formula with no probiotics

Dietary Supplement: Probiotics in infant milk formula

Interventions

Probiotics in infant milk formulaDIETARY_SUPPLEMENT

Probiotic infgant milk formula administered during the forst year of life

Also known as: B.lactis BB12 and L.rhamnosus GG in milk formula
Control milk formulaProbiotics in milk formula

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Child participated in the probiotic milk intervention study in early 2000
  • Child lives now within 100 km from Turku

You may not qualify if:

  • Child has a chronic illness affecting dental health
  • Child lives now outside 100 km from Turku

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Turku

Turku, Finland, 20520, Finland

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Erika M Isolauri, Professor

    University of Turku

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

August 26, 2011

First Posted

August 29, 2011

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 22, 2012

Record last verified: 2012-02

Locations

FI(1)