LGG/BB12-pastille Study

Probiotics Clinical Trial

Official title:

LGG/BB12-pastille Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577485
• Other study ID #: ETMK:22/180/2012
• Status: Completed
• Phase: Phase 1
• First received: April 12, 2012
• Last updated: January 3, 2013
• Start date: August 2012
• Est. completion date: November 2012

Study information

• Verified date: January 2013
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 30 Years

Eligibility

Inclusion Criteria:

• Subjects healthy, 20-30 yrs of age

Exclusion Criteria:

• Subjects not healthy, too old/young

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Probiotics

Intervention

Dietary Supplement:
• Probiotics in an pastille
Test group
• Control pastille
Control group

Locations

Country	Name	City	State
Finland	Institute of Dentistry	Turku

Sponsors (3)

Lead Sponsor	Collaborator
University of Turku	The Forsyth Institute, University of Michigan

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Counts of mutans streptococci		4 weeks	No
Secondary	Amount of plaque		4 weeks	No