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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
Sponsor:
Information provided by (Responsible Party):
Ingegerd Johansson, Umeå University

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.


Condition or disease Intervention/treatment Phase
Dental Plaque Dietary Supplement: Lactobacillus reuteri DSM 17938 and PTA 5289 Dietary Supplement: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult,
  • healthy,
  • no antibiotic treatment and no intake of probiotic products latest 3 months

Exclusion Criteria:

  • Acute or chronic disease at recruitment, medication.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Umeå University
Investigators
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Principal Investigator: Ingegerd Johansson, Professor Umea university, Sweden
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ingegerd Johansson, Professor, Umeå University
ClinicalTrials.gov Identifier: NCT02311218    
Other Study ID Numbers: Umea university
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: November 2014
Keywords provided by Ingegerd Johansson, Umeå University:
oral, microbiota, lactobacillus reuteri,
Additional relevant MeSH terms:
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Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases