GingivitisNAVLAC16NCT02775019
Health Impact of L.Reuteri Consumption in Crew Members of a Naval Ship at Sea
A study testing Lactobacillus reuteri in people with Gingivitis, run by Wuerzburg University Hospital at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Lactobacillus reuteri
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- May 2016to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Minimum of 12 natural teeth
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Gingivitis
- Being tested
- Lactobacillus reuteri, Placebo
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteriDietary supplement
2 x daily repeated consumption of a lozenge containing 10E9 CFU Lactobacillus reuteri for 42 days
PlaceboDietary supplement
2 x daily repeated consumption of a lozenge being void of Lactobacillus reuteri for 42 days
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus reuteri lonzenges | Active comparator | 2x daily repeated intake of lozenges containing 10E9 CFU Lactobacillus reuteri each for 42 days Receives: Dietary Supplement: Lactobacillus reuteri |
| Placebo lozenges | Placebo comparator | 2x daily repeated intake of lozenges being void of Lactobacillus reuteri for 42 days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 42 days
Secondary outcomes (6)
Gingival Index (GI)
Recording of the GI on the vestibular and oral aspects of the Ramfjord teeth (teeth 16, 21, 24, 36, 41, 44)
Measured: 42 days
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)
Measured: 42 days
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
Measured: 42 days
Composition of the oral microbiome
Collection of pooled bacterial biofilm samples from the Ramfjord teeth for subsequent analysis by whole genome sequencing
Measured: 42 days
Composition of the intestinal microbiome
Collection of microbial stool samples for subsequent analysis by whole genome sequencing
Measured: 42 days
Short-term sick leave
Recording of the incidence of short-term sick leave due to gastrointestinal or respiratory diseases
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startMay 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- German Naval Medical Institute
- Responsible party
- Principal investigator, Prof. Dr. Ulrich Schlagenhauf, Wuerzburg University Hospital
- Investigators
- Ulrich Schlagenhauf, Prof. Dr., Principal investigator, Chairman Dept. of Periodontology, University Hospital Wuerzburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775019
- Sponsor's protocol ID
- 02-2016-NAVLAC
- Acronym
- NAVLAC16
- Status last verified
- May 2017
- First submitted
- 13 May 2016
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02775019
- Acronym / sponsor ID
- NAVLAC16 / 02-2016-NAVLAC
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Collaborators
- German Naval Medical Institute
- Study start
- May 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 17 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus reuteri lonzenges | Active comparator | Dietary Supplement: Lactobacillus reuteri2x daily repeated intake of lozenges containing 10E9 CFU Lactobacillus reuteri each for 42 days |
| Placebo lozenges | Placebo comparator | Dietary Supplement: Placebo2x daily repeated intake of lozenges being void of Lactobacillus reuteri for 42 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Minimum of 12 natural teeth
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus reuteri2 x daily repeated consumption of a lozenge containing 10E9 CFU Lactobacillus reuteri for 42 days | Dietary supplement | Lactobacillus reuteri lonzenges |
| Placebo2 x daily repeated consumption of a lozenge being void of Lactobacillus reuteri for 42 days | Dietary supplement | Placebo lozenges |
Primary outcome
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
6 secondary outcomes
Gingival Index (GI)
Time frame: 42 days
Plaque Control Record (PCR)
Time frame: 42 days
Probing Pocket Depth (PPD)
Time frame: 42 days
Composition of the oral microbiome
Time frame: 42 days
Composition of the intestinal microbiome
Time frame: 42 days
Short-term sick leave
Time frame: 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Schlagenhauf, Prof. Dr. principal investigator
Chairman Dept. of Periodontology, University Hospital Wuerzburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus reuteri in people with Gingivitis, run by Wuerzburg University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding on Probing (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.