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Probiotic Lactobacillus Reuteri and Oral Microbiota

NCT02311218 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2014-12-08

No results posted yet for this study

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.

Conditions

  • Dental Plaque

Interventions

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

DIETARY_SUPPLEMENT

Placebo

Placebo lozenges with no Lactobacillus reuteri DSM 17938 and PTA 5289

Sponsors & Collaborators

  • Umeå University

    lead OTHER

Principal Investigators

  • Ingegerd Johansson, Professor · Umea university, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-08-31
Completion
2013-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02311218 on ClinicalTrials.gov