Clinical trial NCT02775019: Health Impact of L.Reuteri Consumption in Crew Members of a Naval Ship at Sea
Official title: Impact of the Daily Consumption of L.Reuteri-containing Lozenges on Oral and General Health in Crew Members of a Naval Ship at Sea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
Collaborators: name: German Naval Medical Institute
First posted: 2016-05-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Bleeding on Probing
timeFrame: 42 days
Secondary outcomes:
measure: Gingival Index (GI)
timeFrame: 42 days
measure: Plaque Control Record (PCR)
timeFrame: 42 days
measure: Probing Pocket Depth (PPD)
timeFrame: 42 days
measure: Composition of the oral microbiome
timeFrame: 42 days
measure: Composition of the intestinal microbiome
timeFrame: 42 days
measure: Short-term sick leave
timeFrame: 42 days
Other outcomes:
Locations:
city: Kronshagen
country: Germany
facility: German Naval Medical Institute
Study officials:
affiliation: Chairman Dept. of Periodontology, University Hospital Wuerzburg, Germany
name: Ulrich Schlagenhauf, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: