ProbioticsNCT04289337
Double-blind Clinical Trials of Probiotic Products in Oral Health.
A study testing Combined probiotics (1), Combined probiotics (2) and Combined heat-killed probiotics (1) in people with Probiotics and Oral Health, run by Glac Biotech Co., Ltd at 1 site in Taiwan.
Trial summary
In order to evaluate the effects of supplementary probiotics and their metabolites on oral environment and oral microbiota, Taiwan FDA No. 88037803 will be used to evaluate the effects of oral probiotic candidate strains from previous research results and develop oral probiotic products. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Probiotics, Oral Health, Probiotic Metabolites
- What is being tested?
- Combined probiotics (1), Combined probiotics (2) and Combined heat-killed probiotics (1)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Oct 2019to 6 Dec 2019
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults between 20 to 40 years old.
- More than 10^5 Streptococcus mutans (CFU/mL) of saliva.
Who cannot join
- Smoking.
- Subject has major illness.
Trial locations and contacts
1 site in 1 country.
About this study
In order to evaluate the effects of supplementary probiotics and their metabolites on oral environment and oral microbiota, Taiwan FDA No. 88037803 will be used to evaluate the effects of oral probiotic candidate strains from previous research results and develop oral probiotic products.
- Conditions
- Probiotics, Oral Health, Probiotic Metabolites
- Being tested
- Combined probiotics (1), Combined probiotics (2), Combined heat-killed probiotics (1), Combined heat-killed probiotics (2), Probiotic metabolites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined probiotics (1)Dietary supplement
Subjects used one oral combined probiotics (1) tablet each morning, noon, and evening for 4 weeks.
Combined probiotics (2)Dietary supplement
Subjects used one oral combined probiotics (2) tablet each morning, noon, and evening for 4 weeks.
Combined heat-killed probiotics (1)Dietary supplement
Subjects used one oral combined heat-killed probiotics (1) tablet each morning, noon, and evening for 4 weeks.
Combined heat-killed probiotics (2)Dietary supplement
Subjects used one oral combined heat-killed probiotics (2) tablet each morning, noon, and evening for 4 weeks.
Probiotic metabolitesDietary supplement
Subjects used one oral probiotic metabolites tablet each morning, noon, and evening for 4 weeks.
PlaceboDietary supplement
Subjects used one oral placebo tablet each morning, noon, and evening for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Combined probiotics (1) | Experimental | Combined Lactobacillus salivarius subsp. salicinius AP-32, Bifidobacterium animalis subsp. lactis CP-9 and Lactobacillus paracasei ET-66. Receives: Dietary Supplement: Combined probiotics (1) |
| Combined probiotics (2) | Experimental | Combined Lactobacillus salivarius subsp. salicinius AP-32, Lactobacillus plantarum LPL28 and Lactobacillus paracasei ET-66. Receives: Dietary Supplement: Combined probiotics (2) |
| Combined heat-killed probiotics (1) | Experimental | Combined heat-killed Lactobacillus salivarius subsp. salicinius AP-32, Bifidobacterium animalis subsp. lactis CP-9 and Lactobacillus paracasei ET-66. Receives: Dietary Supplement: Combined heat-killed probiotics (1) |
| Combined heat-killed probiotics (2) | Experimental | Combined heat-killed Lactobacillus salivarius subsp. salicinius AP-32 and Lactobacillus paracasei ET-66. Receives: Dietary Supplement: Combined heat-killed probiotics (2) |
| Probiotic metabolites | Experimental | Combined Lactobacillus salivarius subsp. salicinius AP-32, Lactobacillus plantarum LPL28 and Lactobacillus paracasei ET-66 metabolites. Receives: Dietary Supplement: Probiotic metabolites |
| Placebo | Placebo comparator | Does not contain probiotics, heat-killed probiotics and related metabolites. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline colony-forming unit (CFU) of Streptococcus mutans at 4 weeks.
The plaque on the inside and outside of teeth was collected by cotton swab and putting in the microbial culture broth before and after taking the oral tablets. The microbial culture broth will be diluted and smeared on the mitis salivarius-bacitracin agar (MSBA) plate for counting the CFU of Streptococcus mutans.
Measured: 4 weeks.
The change from baseline concentration of saliva immunoglobulin A (IgA) at 4 weeks.
The saliva was collected by the centrifuge tube before and after taking the oral tablets. IgA will be detected by enzyme-linked immunosorbent assay (ELISA).
Measured: 4 weeks.
The change from baseline microbiota at 4 weeks.
The saliva was collected by the next-generation sequencing (NGS) saliva collection tube before and after taking the oral tablets. The changes in microbial flora will be detected by NGS.
Measured: 4 weeks.
Secondary outcomes (2)
The change from baseline CFU of total oral microbiota at 4 weeks.
The plaque on the inside and outside of teeth was collected by cotton swab and putting in the microbial culture broth before and after taking the oral tablets. The microbial culture broth will be diluted and smeared on the plate count agar (PCA) plate for counting the CFU of total oral microbiota.
Measured: 4 weeks.
The change from baseline CFU of probiotics at 4 weeks.
The plaque on the inside and outside of teeth was collected by cotton swab and putting in the microbial culture broth before and after taking the oral tablets. The microbial culture broth will be diluted and smeared on the De Man, Rogosa and Sharpe agar (MRSA) plate for counting the CFU of probiotics.
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 posted28 Feb 2020
- Study start21 Oct 2019
- Primary completion2 Dec 2019
- Study completion6 Dec 2019
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Hsieh-Hsun Ho, Glac Biotech Co., Ltd
- Investigators
- Hsieh-Hsun Ho, Ph.D., Principal investigator, Glac Biotech Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289337
- Sponsor's protocol ID
- CS19052
- Status last verified
- Feb 2020
- First submitted
- 24 Feb 2020
- Last updated
- 28 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Clinical Trials of Probiotic Products in Oral Health.
- ClinicalTrials.gov ID
- NCT04289337
- Acronym / sponsor ID
- CS19052
- Conditions
- Probiotics, Oral Health, Probiotic Metabolites
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Glac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 2 Dec 2019 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 28 Feb 2020 (actual)
- 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.
In order to evaluate the effects of supplementary probiotics and their metabolites on oral environment and oral microbiota, Taiwan FDA No. 88037803 will be used to evaluate the effects of oral probiotic candidate strains from previous research results and develop oral probiotic products.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Combined probiotics (1) | Experimental | Dietary Supplement: Combined probiotics (1)Combined Lactobacillus salivarius subsp. salicinius AP-32, Bifidobacterium animalis subsp. lactis CP-9 and Lactobacillus paracasei ET-66. |
| Combined probiotics (2) | Experimental | Dietary Supplement: Combined probiotics (2)Combined Lactobacillus salivarius subsp. salicinius AP-32, Lactobacillus plantarum LPL28 and Lactobacillus paracasei ET-66. |
| Combined heat-killed probiotics (1) | Experimental | Dietary Supplement: Combined heat-killed probiotics (1)Combined heat-killed Lactobacillus salivarius subsp. salicinius AP-32, Bifidobacterium animalis subsp. lactis CP-9 and Lactobacillus paracasei ET-66. |
| Combined heat-killed probiotics (2) | Experimental | Dietary Supplement: Combined heat-killed probiotics (2)Combined heat-killed Lactobacillus salivarius subsp. salicinius AP-32 and Lactobacillus paracasei ET-66. |
| Probiotic metabolites | Experimental | Dietary Supplement: Probiotic metabolitesCombined Lactobacillus salivarius subsp. salicinius AP-32, Lactobacillus plantarum LPL28 and Lactobacillus paracasei ET-66 metabolites. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDoes not contain probiotics, heat-killed probiotics and related metabolites. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults between 20 to 40 years old.
- More than 10^5 Streptococcus mutans (CFU/mL) of saliva.
Key exclusion criteria (2 listed)
- Smoking.
- Subject has major illness.
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 |
|---|---|---|
| Combined probiotics (1)Subjects used one oral combined probiotics (1) tablet each morning, noon, and evening for 4 weeks. | Dietary supplement | Combined probiotics (1) |
| Combined probiotics (2)Subjects used one oral combined probiotics (2) tablet each morning, noon, and evening for 4 weeks. | Dietary supplement | Combined probiotics (2) |
| Combined heat-killed probiotics (1)Subjects used one oral combined heat-killed probiotics (1) tablet each morning, noon, and evening for 4 weeks. | Dietary supplement | Combined heat-killed probiotics (1) |
| Combined heat-killed probiotics (2)Subjects used one oral combined heat-killed probiotics (2) tablet each morning, noon, and evening for 4 weeks. | Dietary supplement | Combined heat-killed probiotics (2) |
| Probiotic metabolitesSubjects used one oral probiotic metabolites tablet each morning, noon, and evening for 4 weeks. | Dietary supplement | Probiotic metabolites |
| PlaceboSubjects used one oral placebo tablet each morning, noon, and evening for 4 weeks. | Dietary supplement | Placebo |
Primary outcome
The change from baseline colony-forming unit (CFU) of Streptococcus mutans at 4 weeks.
Time frame: 4 weeks.
The plaque on the inside and outside of teeth was collected by cotton swab and putting in the microbial culture broth before and after taking the oral tablets. The microbial culture broth will be diluted and smeared on the mitis salivarius-bacitracin agar (MSBA) plate for counting the CFU of Streptococcus mutans.
The change from baseline concentration of saliva immunoglobulin A (IgA) at 4 weeks.
Time frame: 4 weeks.
The saliva was collected by the centrifuge tube before and after taking the oral tablets. IgA will be detected by enzyme-linked immunosorbent assay (ELISA).
The change from baseline microbiota at 4 weeks.
Time frame: 4 weeks.
The saliva was collected by the next-generation sequencing (NGS) saliva collection tube before and after taking the oral tablets. The changes in microbial flora will be detected by NGS.
2 secondary outcomes
The change from baseline CFU of total oral microbiota at 4 weeks.
Time frame: 4 weeks.
The change from baseline CFU of probiotics at 4 weeks.
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 28 Feb 2020.
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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.
Hsieh-Hsun Ho, Ph.D. principal investigator
Glac Biotech Co., Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined probiotics (1), Combined probiotics (2) and Combined heat-killed probiotics (1) in people with Probiotics and Oral Health, run by Glac Biotech Co., Ltd at 1 site in Taiwan.
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 2 inclusion and 2 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 28 Feb 2020. 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 Taiwan. 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?
The change from baseline colony-forming unit (CFU) of Streptococcus mutans at 4 weeks. (time frame: 4 weeks.). The study lists 3 primary outcomes in all. 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 28 Feb 2020.