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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

April 12, 2012
January 3, 2013
August 2012
November 2012   (final data collection date for primary outcome measure)
Counts of mutans streptococci [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01577485 on ClinicalTrials.gov Archive Site
Amount of plaque [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
LGG/BB12-pastille Study
LGG/BB12-pastille Study

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Probiotics
  • Dietary Supplement: Probiotics in an pastille
    Test group
  • Dietary Supplement: Control pastille
    Control group
  • Experimental: Probiotic pastille
    Test group
    Intervention: Dietary Supplement: Probiotics in an pastille
  • Active Comparator: Control pastille
    Control group
    Intervention: Dietary Supplement: Control pastille
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects healthy, 20-30 yrs of age

Exclusion Criteria:

  • Subjects not healthy, too old/young
Both
20 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01577485
ETMK:22/180/2012
No
Eva Soderling, University of Turku
University of Turku
  • University of Michigan
  • The Forsyth Institute
Principal Investigator: Eva M Söderling Associate Professor
University of Turku
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP