HyposalivationPhase 1NCT02677480
The Effect of Probiotic Streptococci and pH-rising Components on the Oral Microbial Flora
A Phase 1 study testing Test group, probiotic tablets and gel in people with Hyposalivation, run by Göteborg University at 1 site in Sweden.
Trial summary
The test group consisted of eighteen subjects with hyposalivation used probiotic tablets (≥ 4/day) and gel (once a week) (streptococci, bicarbonate and carbamide) for 3 months and 9 used placebo tablets and gel. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyposalivation
- What is being tested?
- Test group, probiotic tablets and gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2010to Nov 2010
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No open wounds in the oral cavity
- ≥ 10 own teeth
- Experienced dry mouth for at least 1 year
- An unstimulated salivary secretion rate < 0.1 ml/min
- A stimulated secretion rate < 0.7 ml/min and high numbers (≥ 10000 cfu/ml) of lactobacilli and/or mutans streptococci on the tongue and/or in dental plaque
Who cannot join
- Removable prosthesis
- Reduced immune defence
- Serious heart diseases
- Implanted joints or heart valves
- Lactose intolerance (the probiotic streptococci are freeze-dried in skim milk)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Probiotic Streptococci and pH-rising Components on the Oral Microbial Flora in Subjects With Reduced Salivary Secretion Rate
The test group consisted of eighteen subjects with hyposalivation used probiotic tablets (≥ 4/day) and gel (once a week) (streptococci, bicarbonate and carbamide) for 3 months and 9 used placebo tablets and gel. The salivary secretion rates were measured and microbial samples collected and analysed using cultivation technique twice both at baseline and at the 3-month follow up (1-2 weeks between the appointments).
Read the detailed description
The aim was to analyse the effect of daily intake of probiotic alpha-haemolytic facultative anaerobic streptococci (Streptococcus oralis), pH-rising components and Stevia on the oral microflora in hyposalivated subjects.
Material and methods: Subjects with hyposalivation (unstimulated secretion rate of < 0.1 ml/min and/or a stimulated secretion rate < 0.7 ml/min) and ≥ 10 000 cfu/ml of mutans streptococci and/or lactobacilli on the tongue or in the supragingival plaque were included. Eighteen subjects used probiotic tablets (≥ 4/day) and gel (once a week) for 3 months and 9 used placebo tablets and gel. The salivary secretion rates were measured and microbial samples collected and analysed using cultivation technique twice both at baseline and at the 3-month follow up (1-2 weeks between the appointments).
- Conditions
- Hyposalivation
- Being tested
- Test group, probiotic tablets and gel, Placebo group, placebo tablets and gel
- Keywords
- Microflora, Probiotics, Hyposalivation, Lactobacilli, Mutans streptococci, pH-rising components
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test group, probiotic tablets and gelDietary supplement
Effect of probiotic tablets and gel on acidogenic bacteria
Placebo group, placebo tablets and gelDietary supplement
Effect of placebo tablets and gel on acidogenic bacteria
| Study group | Role | What they receive |
|---|---|---|
| Test group, probiotic tablets and gel | Active comparator | Test group, probiotic tablets and gel: tablets with probiotic bacteria (10exp8/tablet) and pH-rising components and gel (with probiotic bacteria and pH-rising components) in trays on the teeth once a week. Receives: Dietary Supplement: Test group, probiotic tablets and gel |
| Placebo group, placebo tablets and gel | Placebo comparator | Placebo group, placebo tablets and gel: placebo tablets without probiotic bacteria and pH-rising components and gel (with no probiotic bacteria but with pH-rising components) in trays on the teeth once a week. Receives: Dietary Supplement: Placebo group, placebo tablets and gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of proportions of mutans streptococci and/or lactobacilli in supragingival plaque and/or on the tongue at 3 months compared with baseline
The oral microflora of patients with hyposalivation (unstimulated secretion rate ≤ 0.1 ml/min and/or a stimulated secretion rate ≤ 0.7 ml/min) is analysed. Samples are collected from supragingival plaque and from the tongue and are analysed using cultivation techniques. The total microbial count is registered as well as numbers of streptococci, mutans streptococci and lactobacilli. Patients with counts of mutans streptococci and/or lactobacilli ≥ 10000 colony forming units/ml are randomly included in either the test group or in the placebo group. After 3 months, microbial samples are collected again from supragingival plaque and from the tongue and proportions of microorganisms analysed. Statistically significant differences in proportions of mutans streptococci and lactobacilli between baseline and after 3 months will be analysed using Students' paired t-test.
Measured: 3 months
Secondary outcomes (1)
Reduction of numbers of mutans streptococci and/or lactobacilli in supragingival plaque and/or on the tongue at 3 months compared with baseline
The oral microflora of patients with hyposalivation (unstimulated secretion rate ≤ 0.1 ml/min and/or a stimulated secretion rate ≤ 0.7 ml/min) is analysed. Samples are collected from supragingival plaque and from the tongue and are analysed using cultivation techniques. The total microbial count is registered as well as numbers of streptococci, mutans streptococci and lactobacilli. Patients with counts of mutans streptococci and/or lactobacilli ≥ 10000 colony forming units/ml are randomly included in either the test group or in the placebo group. After 3 months, microbial samples are collected again from supragingival plaque and from the tongue and the numbers of microorganisms analysed. Statistically significant differences in numbers of mutans streptococci and lactobacilli between baseline and after 3 months will be analysed using Students' paired t-test.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startNov 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyposalivationStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Vinnova, Vastra Gotaland Region
- Responsible party
- Sponsor
- Investigators
- Annica Almstahl, Assoc. prof., Principal investigator, Goteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677480
- Sponsor's protocol ID
- 662-08
- Status last verified
- Feb 2016
- First submitted
- 19 Nov 2015
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotic Streptococci and pH-rising Components on the Oral Microbial Flora in Subjects With Reduced Salivary Secretion Rate
- ClinicalTrials.gov ID
- NCT02677480
- Acronym / sponsor ID
- 662-08
- Conditions
- Hyposalivation
- Keywords
- Microflora, Probiotics, Hyposalivation, Lactobacilli, Mutans streptococci, pH-rising components
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Vinnova, Vastra Gotaland Region
- Study start
- Nov 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 9 Feb 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.
The test group consisted of eighteen subjects with hyposalivation used probiotic tablets (≥ 4/day) and gel (once a week) (streptococci, bicarbonate and carbamide) for 3 months and 9 used placebo tablets and gel. The salivary secretion rates were measured and microbial samples collected and analysed using cultivation technique twice both at baseline and at the 3-month follow up (1-2 weeks between the appointments).
Detailed description
The aim was to analyse the effect of daily intake of probiotic alpha-haemolytic facultative anaerobic streptococci (Streptococcus oralis), pH-rising components and Stevia on the oral microflora in hyposalivated subjects.
Material and methods: Subjects with hyposalivation (unstimulated secretion rate of < 0.1 ml/min and/or a stimulated secretion rate < 0.7 ml/min) and ≥ 10 000 cfu/ml of mutans streptococci and/or lactobacilli on the tongue or in the supragingival plaque were included. Eighteen subjects used probiotic tablets (≥ 4/day) and gel (once a week) for 3 months and 9 used placebo tablets and gel. The salivary secretion rates were measured and microbial samples collected and analysed using cultivation technique twice both at baseline and at the 3-month follow up (1-2 weeks between the appointments).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group, probiotic tablets and gel | Active comparator | Dietary Supplement: Test group, probiotic tablets and gelTest group, probiotic tablets and gel: tablets with probiotic bacteria (10exp8/tablet) and pH-rising components and gel (with probiotic bacteria and pH-rising components) in trays on the teeth once a week. |
| Placebo group, placebo tablets and gel | Placebo comparator | Dietary Supplement: Placebo group, placebo tablets and gelPlacebo group, placebo tablets and gel: placebo tablets without probiotic bacteria and pH-rising components and gel (with no probiotic bacteria but with pH-rising components) in trays on the teeth once a week. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- No open wounds in the oral cavity
- ≥ 10 own teeth
- Experienced dry mouth for at least 1 year
- An unstimulated salivary secretion rate < 0.1 ml/min
- A stimulated secretion rate < 0.7 ml/min and high numbers (≥ 10000 cfu/ml) of lactobacilli and/or mutans streptococci on the tongue and/or in dental plaque
Key exclusion criteria (5 listed)
- Removable prosthesis
- Reduced immune defence
- Serious heart diseases
- Implanted joints or heart valves
- Lactose intolerance (the probiotic streptococci are freeze-dried in skim milk)
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 |
|---|---|---|
| Test group, probiotic tablets and gelEffect of probiotic tablets and gel on acidogenic bacteria | Dietary supplement | Test group, probiotic tablets and gel |
| Placebo group, placebo tablets and gelEffect of placebo tablets and gel on acidogenic bacteria | Dietary supplement | Placebo group, placebo tablets and gel |
Primary outcome
Reduction of proportions of mutans streptococci and/or lactobacilli in supragingival plaque and/or on the tongue at 3 months compared with baseline
Time frame: 3 months
The oral microflora of patients with hyposalivation (unstimulated secretion rate ≤ 0.1 ml/min and/or a stimulated secretion rate ≤ 0.7 ml/min) is analysed. Samples are collected from supragingival plaque and from the tongue and are analysed using cultivation techniques. The total microbial count is registered as well as numbers of streptococci, mutans streptococci and lactobacilli. Patients with counts of mutans streptococci and/or lactobacilli ≥ 10000 colony forming units/ml are randomly included in either the test group or in the placebo group. After 3 months, microbial samples are collected again from supragingival plaque and from the tongue and proportions of microorganisms analysed. Statistically significant differences in proportions of mutans streptococci and lactobacilli between baseline and after 3 months will be analysed using Students' paired t-test.
1 secondary outcome
Reduction of numbers of mutans streptococci and/or lactobacilli in supragingival plaque and/or on the tongue at 3 months compared with baseline
Time frame: 3 months
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 Feb 2016.
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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.
Annica Almstahl, Assoc. prof. principal investigator
Goteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Test group, probiotic tablets and gel in people with Hyposalivation, run by Göteborg University at 1 site in Sweden.
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 5 inclusion and 5 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 Feb 2016. 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 Sweden. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction of proportions of mutans streptococci and/or lactobacilli in supragingival plaque and/or on the tongue at 3 months compared with baseline (time frame: 3 months). 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 Feb 2016.