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Health Impact of L.Reuteri Consumption in Crew Members of a Naval Ship at Sea (NAVLAC16)

W

Wuerzburg University Hospital

Status

Completed

Conditions

Gingivitis

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Lactobacillus reuteri

Study type

Interventional

Funder types

Other

Identifiers

NCT02775019
02-2016-NAVLAC

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

72 participants in 2 patient groups, including a placebo group

Lactobacillus reuteri lonzenges
Active Comparator group
Description:
2x daily repeated intake of lozenges containing 10E9 CFU Lactobacillus reuteri each for 42 days
Treatment:
Dietary Supplement: Lactobacillus reuteri
Placebo lozenges
Placebo Comparator group
Description:
2x daily repeated intake of lozenges being void of Lactobacillus reuteri for 42 days.
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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