Probiotic Lactobacillus Reuteri and Oral Microbiota (OMICI)
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|ClinicalTrials.gov Identifier: NCT02311218|
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : December 8, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Dental Plaque||Dietary Supplement: Lactobacillus reuteri DSM 17938 and PTA 5289 Dietary Supplement: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Oral Microbiota Shift After 12-week Supplementation With Lactobacillus Reuteri DSM 17938 and PTA 5289|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
Active Comparator: Test group with L. reuteri
Subjects in the test group take one Lactobacillus reuteri DSM 17938 and PTA 5289 containing lozenge in the morning and one in the evening.
Dietary Supplement: Lactobacillus reuteri DSM 17938 and PTA 5289
Subjects in the test group are given one lozenges with Lactobacillus reuteri DSM 17938 and PTA 5289 in the morning and one in the evening
Placebo Comparator: Placebo group without L. reuteri
Subjects in the placebo group take one placebo lozenges with same look, taste and smell as the test lozenge but lacking the Lactobacillii the morning and one in the evening.
Dietary Supplement: Placebo
Placebo lozenges with no Lactobacillus reuteri DSM 17938 and PTA 5289
- 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 ]The change in bacteria colonizing the oral cavity after 12 weeks treatment with L. reuteri is analyzed
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): NCT02311218
|Principal Investigator:||Ingegerd Johansson, Professor||Umea university, Sweden|