This study is designed to evaluate the impact of the regular consumption of probiotic Lactobacillus 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.
Probiotic strains of Lactobacillus reuteri have demonstrated a significant impact on the composition of the oral and intestinal microbiome as well as modulating the host response in several clinical trials and in vitro experiments. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
72
2 x daily repeated consumption of a lozenge containing 10E9 CFU Lactobacillus reuteri for 42 days
2 x daily repeated consumption of a lozenge being void of Lactobacillus reuteri for 42 days
German Naval Medical Institute
Kronshagen, Germany
Bleeding on Probing
Number of sites being positive for bleeding on probing on the Ramfjord teeth (teeth 16, 21, 24, 36, 41, 44) with 6 probing sites per tooth
Time frame: 42 days
Gingival Index (GI)
Recording of the GI on the vestibular and oral aspects of the Ramfjord teeth (teeth 16, 21, 24, 36, 41, 44)
Time frame: 42 days
Plaque Control Record (PCR)
Recording of the PCR on the vestibular and oral aspects of the Ramfjord teeth (teeth 16, 21, 24, 36, 41, 44)
Time frame: 42 days
Probing Pocket Depth (PPD)
Recording of the PPD at the Ramfjord teeth (teeth 16, 21, 24, 36, 41, 44) with 6 probing sites per tooth
Time frame: 42 days
Composition of the oral microbiome
Collection of pooled bacterial biofilm samples from the Ramfjord teeth for subsequent analysis by whole genome sequencing
Time frame: 42 days
Composition of the intestinal microbiome
Collection of microbial stool samples for subsequent analysis by whole genome sequencing
Time frame: 42 days
Short-term sick leave
Recording of the incidence of short-term sick leave due to gastrointestinal or respiratory diseases
Time frame: 42 days
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