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LGG/BB12-pastille Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01577485
First Posted: April 13, 2012
Last Update Posted: January 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Michigan
The Forsyth Institute
Information provided by (Responsible Party):
Eva Soderling, University of Turku
  Purpose
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.

Condition Intervention Phase
Probiotics Dietary Supplement: Probiotics in an pastille Dietary Supplement: Control pastille Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: LGG/BB12-pastille Study

Further study details as provided by Eva Soderling, University of Turku:

Primary Outcome Measures:
  • Counts of mutans streptococci [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Amount of plaque [ Time Frame: 4 weeks ]

Enrollment: 60
Study Start Date: August 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotic pastille
Test group
Dietary Supplement: Probiotics in an pastille
Test group
Active Comparator: Control pastille
Control group
Dietary Supplement: Control pastille
Control group

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects healthy, 20-30 yrs of age

Exclusion Criteria:

  • Subjects not healthy, too old/young
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01577485


Locations
Finland
Institute of Dentistry
Turku, Finland, 20520
Sponsors and Collaborators
University of Turku
University of Michigan
The Forsyth Institute
Investigators
Principal Investigator: Eva M Söderling Associate Professor
  More Information

Responsible Party: Eva Soderling, Associate Professor, University of Turku
ClinicalTrials.gov Identifier: NCT01577485     History of Changes
Other Study ID Numbers: ETMK:22/180/2012
First Submitted: April 12, 2012
First Posted: April 13, 2012
Last Update Posted: January 4, 2013
Last Verified: January 2013