Health Impact of L.Reuteri Consumption in Crew Members of a Naval Ship at Sea
NAVLAC16
Impact of the Daily Consumption of L.Reuteri-containing Lozenges on Oral and General Health in Crew Members of a Naval Ship at Sea
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 13, 2016
CompletedFirst Posted
Study publicly available on registry
May 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedMay 9, 2017
May 1, 2017
3 months
May 13, 2016
May 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Gingival Index (GI)
42 days
Plaque Control Record (PCR)
42 days
Probing Pocket Depth (PPD)
42 days
Composition of the oral microbiome
42 days
Composition of the intestinal microbiome
42 days
- +1 more secondary outcomes
Study Arms (2)
Lactobacillus reuteri lonzenges
ACTIVE COMPARATOR2x daily repeated intake of lozenges containing 10E9 CFU Lactobacillus reuteri each for 42 days
Placebo lozenges
PLACEBO COMPARATOR2x daily repeated intake of lozenges being void of Lactobacillus reuteri for 42 days.
Interventions
2 x daily repeated consumption of a lozenge containing 10E9 CFU Lactobacillus reuteri for 42 days
2 x daily repeated consumption of a lozenge being void of Lactobacillus reuteri for 42 days
Eligibility Criteria
You may qualify if:
- Minimum of 12 natural teeth
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wuerzburg University Hospitallead
- German Naval Medical Institutecollaborator
Study Sites (1)
German Naval Medical Institute
Kronshagen, 24119, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ulrich Schlagenhauf, Prof. Dr.
Chairman Dept. of Periodontology, University Hospital Wuerzburg, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- chairman Dept. of Periodontology
Study Record Dates
First Submitted
May 13, 2016
First Posted
May 17, 2016
Study Start
May 1, 2016
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
May 9, 2017
Record last verified: 2017-05