Health Impact of L.Reuteri Consumption in Crew Members of a Naval Ship at Sea

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of the Daily Consumption of L.Reuteri-containing Lozenges on Oral and General Health in Crew Members of a Naval Ship at Sea

Conditions
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Gingivitis

Intervention / Treatment
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* Dietary Supplement: Lactobacillus reuteri
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum of 12 natural teeth Exclusion Criteria: Regular intake of antiinflammatory drugs affecting periodontal health (e.g. NSAIDs) Manifestation of systemic disease affecting periodontal health (e.g. diabetes) Use of antiseptic oral mouthrinses Drug/alcohol abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lactobacillus reuteri lonzenges<br>2x daily repeated intake of lozenges containing 10E9 CFU Lactobacillus reuteri each for 42 days | Dietary Supplement: Lactobacillus reuteri<br>* 2 x daily repeated consumption of a lozenge containing 10E9 CFU Lactobacillus reuteri for 42 days<br>|
| Placebo Comparator: Placebo lozenges<br>2x daily repeated intake of lozenges being void of Lactobacillus reuteri for 42 days. | Dietary Supplement: Placebo<br>* 2 x daily repeated consumption of a lozenge being void of Lactobacillus reuteri for 42 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival Index (GI) | Recording of the GI on the vestibular and oral aspects of the Ramfjord teeth (teeth 16, 21, 24, 36, 41, 44) | 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) | 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 | 42 days | 
| Composition of the oral microbiome | Collection of pooled bacterial biofilm samples from the Ramfjord teeth for subsequent analysis by whole genome sequencing | 42 days | 
| Composition of the intestinal microbiome | Collection of microbial stool samples for subsequent analysis by whole genome sequencing | 42 days | 
| Short-term sick leave | Recording of the incidence of short-term sick leave due to gastrointestinal or respiratory diseases | 42 days |