LGG/BB12-pastille Study

This study has been completed.
Sponsor:
Collaborators:
University of Michigan
The Forsyth Institute
Information provided by (Responsible Party):
Eva Soderling, University of Turku
ClinicalTrials.gov Identifier:
NCT01577485
First received: April 12, 2012
Last updated: January 3, 2013
Last verified: January 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: LGG/BB12-pastille Study

Further study details as provided by University of Turku:

Primary Outcome Measures:
  • Counts of mutans streptococci [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amount of plaque [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 30 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Eva Soderling, Associate Professor, University of Turku
ClinicalTrials.gov Identifier: NCT01577485     History of Changes
Other Study ID Numbers: ETMK:22/180/2012
Study First Received: April 12, 2012
Last Updated: January 3, 2013
Health Authority: Finland: Ethics Committee

ClinicalTrials.gov processed this record on April 16, 2014