Skip to main content
OpenTrials
Completed

NCT Number: NCT02775019

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

German Naval Medical Institute

Kronshagen, 24119, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus reuteri

Dietary Supplement

2 x daily repeated consumption of a lozenge containing 10E9 CFU Lactobacillus reuteri for 42 days

Placebo

Dietary Supplement

2 x daily repeated consumption of a lozenge being void of Lactobacillus reuteri for 42 days

Primary outcomes

  1. Bleeding on Probing

    Time frame: 42 days

    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

Secondary outcomes

  1. Gingival Index (GI)

    Time frame: 42 days

    Recording of the GI on the vestibular and oral aspects of the Ramfjord teeth (teeth 16, 21, 24, 36, 41, 44)

  2. Plaque Control Record (PCR)

    Time frame: 42 days

    Recording of the PCR on the vestibular and oral aspects of the Ramfjord teeth (teeth 16, 21, 24, 36, 41, 44)

  3. Probing Pocket Depth (PPD)

    Time frame: 42 days

    Recording of the PPD at the Ramfjord teeth (teeth 16, 21, 24, 36, 41, 44) with 6 probing sites per tooth

  4. Composition of the oral microbiome

    Time frame: 42 days

    Collection of pooled bacterial biofilm samples from the Ramfjord teeth for subsequent analysis by whole genome sequencing

  5. Composition of the intestinal microbiome

    Time frame: 42 days

    Collection of microbial stool samples for subsequent analysis by whole genome sequencing

  6. Short-term sick leave

    Time frame: 42 days

    Recording of the incidence of short-term sick leave due to gastrointestinal or respiratory diseases

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Collaborators

  • German Naval Medical Institute

Registry information

Official study 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

Acronym: NAVLAC16

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 17, 2016
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.