NCT01577485

Brief Summary

We want to study the effect of short-term consumption of probiotics (a mixture of L. rhamnosus GG and B. lactis BB-12)on the composition of the oral flora.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

April 12, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

January 4, 2013

Status Verified

January 1, 2013

Enrollment Period

3 months

First QC Date

April 12, 2012

Last Update Submit

January 3, 2013

Conditions

Probiotics

Outcome Measures

Primary Outcomes (1)

  • Counts of mutans streptococci

    4 weeks

Secondary Outcomes (1)

  • Amount of plaque

    4 weeks

Study Arms (2)

Probiotic pastille

EXPERIMENTAL

Test group

Dietary Supplement: Probiotics in an pastille

Control pastille

ACTIVE COMPARATOR

Control group

Dietary Supplement: Control pastille

Interventions

Probiotics in an pastilleDIETARY_SUPPLEMENT

Test group

Probiotic pastille
Control pastilleDIETARY_SUPPLEMENT

Control group

Control pastille

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects healthy, 20-30 yrs of age

You may not qualify if:

  • Subjects not healthy, too old/young

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Dentistry

Turku, 20520, Finland

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Eva M Söderling

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 12, 2012

First Posted

April 13, 2012

Study Start

August 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

January 4, 2013

Record last verified: 2013-01

Locations

FI(1)