Clinical Trial: Probiotic Lactobacillus Reuteri and Oral Microbiota

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Oral Microbiota Shift After 12-week Supplementation With Lactobacillus Reuteri DSM 17938 and PTA 5289

Brief Summary:

In February 2013, 44 healthy adults was recruited and randomized to daily intake of lozenges with or without Lactobacillus reuteri strains DSM 17938 and PTA 5289 for 12 weeks. The effect of these Lactobacillus reuteri strains on the oral microbial composition was monitored before, after 4, 8 and 12 weeks and after 1 and 6 months after exposure was completed. For this purpose saliva and tooth plaque was collected. Of 44 included subjects, 41 completed the study. The used Lactobacillus reuteri containing lozenges are commercially available and identical placebo lozenges was obtained from the manufacturer. The study product was well tolerated with no observed side effects. Compliance was excellent.

The investigators' primary outcome was to determine whether daily intake of Lactobacillus reuteri strains DSM 17938 and PTA 5289 for 12 weeks alters the tooth colonizing bacterial plaque composition determined by a multiplex sequencing technique. Effects are put in relation to general knowledge on bacterial profiles associated with risk to develop dental caries and periodontitis.

Detailed Summary:

Ethics statements The study was approved by the Regional Ethical Review Board in Umeå, Sweden (Dnr 2011-380-31M) and was conducted according to the principles expressed in the Declaration of Helsinki. Written informed consent was obtained from all participants.

Subjects and study design Healthy adult volunteers, aged 20-66 years, among students and employees at the Faculty of Medicine, Umeå University, Sweden were recruited to a double-blind, randomized controlled trial (RCT) through advertisements. Inclusion criteria were a self-reported healthy status and no use of antibiotics or probiotic products during 3 months prior to the study. Based on previous studies regarding the persistence of probiotic strains [31,32], the recruitment goal was at least 15 people per study group.

Forty-four volunteers, none of whom used tobacco products, were recruited and randomly allocated to either a test (n = 22) or placebo group (n = 22; Figure S1). Participants were asked to allow 2 lozenges per day to slowly melt in the mouth and to circulate the dissolved tablet contents around their mouths. One lozenge was taken in the morning and 1 in the evening for 12 weeks. The test lozenges contained L. reuteri (DSM 17938 and PTA 5289; 108 CFU per strain; BioGaia AB, Stockholm, Sweden), isomalt, hydrogenated palm oil, peppermint and menthol flavoring, peppermint oil, and sucralose (http://www.biogaia.com/product/biogaia-prodentis-oral-lozenges). The placebo lozenges were identical to the test lozenges in appearance, taste, and composition except the lactobacilli. Compliance was monitored as the percentage of lozenges consumed of the total assigned number. The remaining lozenges were counted when the containers were returned for monthly refills to assess this factor. Compliance was considered acceptable if ≤15% of the lozenges rema
Sponsor: Umeå University

Current Primary Outcome: Change in oral bacteria biofilm composition after 12-week supplementation with Lactobacillus reuteri DSM 17938 and PTA 5289 [ Time Frame: Baseline, after 4, 8 and 12 week treatment, and 1 and 6 months after treatment has terminated ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Umeå University

Dates:
Date Received: November 23, 2014
Date Started: March 2013
Date Completion:
Last Updated: December 4, 2014
Last Verified: November 2014