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

Gingivitis Clinical Trial

— NAVLAC16  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02775019
• Other study ID #: 02-2016-NAVLAC
• Status: Completed
• Phase: N/A
• First received: May 13, 2016
• Last updated: May 8, 2017
• Start date: May 2016
• Est. completion date: August 2016

Study information

• Verified date: May 2017
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingivitis

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Germany	German Naval Medical Institute	Kronshagen

Sponsors (2)

Lead Sponsor	Collaborator
Wuerzburg University Hospital	German Naval Medical Institute

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Composition of the oral microbiome	Collection of pooled bacterial biofilm samples from the Ramfjord teeth for subsequent analysis by whole genome sequencing	42 days
Secondary	Composition of the intestinal microbiome	Collection of microbial stool samples for subsequent analysis by whole genome sequencing	42 days
Secondary	Short-term sick leave	Recording of the incidence of short-term sick leave due to gastrointestinal or respiratory diseases	42 days