Health Impact of L.Reuteri Consumption in Crew Members of a Naval Ship at Sea
NCT ID: NCT02775019
Last Updated: 2017-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2016-05-31
2016-08-31
Brief Summary
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Detailed Description
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This two-arm double blind placebo controlled clinical trial will evaluate the impact of the regular consumption of L.reuteri-containing lozenges over a period of 42 days on parameters of oral and general health in crew members of a naval ship at sea.
2 x 36 healthy study subjects will be recruited from the crew members of the ship.
At baseline and at the end of the study (day 42) the following parameters will be recorded at the Ramfjord teeth (teeth 16, 21, 24, 36, 41, 44):
Bleeding on Probing (BoP) as the primary outcome
Secondary outcomes will be Gingival Index (GI) Plaque Control Record (PCR) Pocket Probing Depth (PPD) Pooled oral and intestinal (stool) microbial samples will be taken at baseline and at the end of the study for the subsequent analysis of the
* composition of the oral microbiome
* composition of the intestinal microbiome by whole genome sequencing
Furthermore the frequency of short-term sick leave due to respiratory or intestinal diseases among the study participants during the observation period will be recorded.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Lactobacillus reuteri lonzenges
2x daily repeated intake of lozenges containing 10E9 CFU Lactobacillus reuteri each for 42 days
Lactobacillus reuteri
2 x daily repeated consumption of a lozenge containing 10E9 CFU Lactobacillus reuteri for 42 days
Placebo lozenges
2x daily repeated intake of lozenges being void of Lactobacillus reuteri for 42 days.
Placebo
2 x daily repeated consumption of a lozenge being void of Lactobacillus reuteri for 42 days
Interventions
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Lactobacillus reuteri
2 x daily repeated consumption of a lozenge containing 10E9 CFU Lactobacillus reuteri for 42 days
Placebo
2 x daily repeated consumption of a lozenge being void of Lactobacillus reuteri for 42 days
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
Yes
Sponsors
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German Naval Medical Institute
OTHER
Wuerzburg University Hospital
OTHER
Responsible Party
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Prof. Dr. Ulrich Schlagenhauf
chairman Dept. of Periodontology
Principal Investigators
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Ulrich Schlagenhauf, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Chairman Dept. of Periodontology, University Hospital Wuerzburg, Germany
Locations
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German Naval Medical Institute
Kronshagen, , Germany
Countries
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Other Identifiers
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02-2016-NAVLAC
Identifier Type: -
Identifier Source: org_study_id
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