ProbioticsPhase 1NCT01577485
LGG/BB12-pastille Study
A Phase 1 study testing Probiotics in an pastille in people with Probiotics, run by University of Turku at 1 site in Finland.
Trial summary
We want to study the effect of short-term consumption of probiotics (a mixture of L. rhamnosus GG and B. lactis BB-12)on the composition of the oral flora. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Probiotics
- What is being tested?
- Probiotics in an pastille
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2012to Nov 2012
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects healthy, 20-30 yrs of age
Who cannot join
- Subjects not healthy, too old/young
Trial locations and contacts
1 site in 1 country.
About this study
We want to study the effect of short-term consumption of probiotics (a mixture of L. rhamnosus GG and B. lactis BB-12)on the composition of the oral flora.
- Conditions
- Probiotics
- Being tested
- Probiotics in an pastille, Control pastille
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics in an pastilleDietary supplement
Test group
Control pastilleDietary supplement
Control group
| Study group | Role | What they receive |
|---|---|---|
| Probiotic pastille | Experimental | Test group Receives: Dietary Supplement: Probiotics in an pastille |
| Control pastille | Active comparator | Control group Receives: Dietary Supplement: Control pastille |
What is being measured
The primary outcome is the main question the study is designed to answer.
Counts of mutans streptococci
Measured: 4 weeks
Secondary outcomes (1)
Amount of plaque
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startAug 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProbioticsStudies 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 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, The Forsyth Institute
- Responsible party
- Principal investigator, Eva Soderling, University of Turku
- Investigators
- Eva M Söderling, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577485
- Sponsor's protocol ID
- ETMK:22/180/2012
- Status last verified
- Jan 2013
- First submitted
- 12 Apr 2012
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LGG/BB12-pastille Study
- ClinicalTrials.gov ID
- NCT01577485
- Acronym / sponsor ID
- ETMK:22/180/2012
- Conditions
- Probiotics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- University of Michigan, The Forsyth Institute
- Study start
- Aug 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 13 Apr 2012 (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.
We want to study the effect of short-term consumption of probiotics (a mixture of L. rhamnosus GG and B. lactis BB-12)on the composition of the oral flora.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic pastille | Experimental | Dietary Supplement: Probiotics in an pastilleTest group |
| Control pastille | Active comparator | Dietary Supplement: Control pastilleControl group |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects healthy, 20-30 yrs of age
Key exclusion criteria (1 listed)
- Subjects not healthy, too old/young
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 |
|---|---|---|
| Probiotics in an pastilleTest group | Dietary supplement | Probiotic pastille |
| Control pastilleControl group | Dietary supplement | Control pastille |
Primary outcome
Counts of mutans streptococci
Time frame: 4 weeks
1 secondary outcome
Amount of plaque
Time frame: 4 weeks
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 4 Jan 2013.
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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.
Eva M Söderling principal investigator
Associate Professor
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 Probiotics in an pastille in people with Probiotics, run by University of Turku at 1 site in Finland.
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 4 Jan 2013. 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 Finland. 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. 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?
Counts of mutans streptococci (time frame: 4 weeks). 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 4 Jan 2013; AzTrials last refreshed its copy on 28 Oct 2026.