Dental CariesNCT05123651
Research on the Characteristics and Application of Lactobacillus Rhamnosus X253 as Oral Probiotics
A study testing Lactobacillus rhamnosus X253 in people with Dental Caries, run by Junlebao Dairy Group Co., Ltd. at 1 site in China.
Trial summary
The aim of the study is to study the application of Lactobacillus rhamnosus X253 as oral probiotics by the way of a randomised, double blinded, parallel, placebo-controlled clinical trial, and to eto detect the changes in oral flora of volunteers, and judge the improvement effect of X253 lozenges on the human oral… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Lactobacillus rhamnosus X253
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 2 Mar 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- Age: 18 years old and above;
- Gender: There is no restriction on men or women (women are not pregnant);
- Keep more than 20 original teeth in the oral cavity;
- Have not had periodontal treatment, tooth whitening (ceramic veneer, cold light whitening), orthodontics, etc. in the past 6 months;
- No oral topical medication (such as mouthwash, watermelon frost) within 1 month;
- No dental filling plan in the next 2-6 weeks;
- Have not taken antibiotics (such as amoxicillin, cephalosporin, roxithromycin, ofloxacin, etc.), hormones (such as glucocorticoids, thyroid hormones, insulin, etc.) and immunosuppressive agents(such as dexamethasone, methylprednisolone, sirolimus, azathioprine) in the past half month; no taking plan for antibiotics (such as amoxicillin, cephalosporin, roxithromycin, ofloxacin, etc.), hormones (such as glucocorticoids, thyroid hormones, insulin, etc.) and immunosuppressive agents (such as dexamethasone, methylprednisolone, sirolimus, azathioprine) within the next 2-6 weeks;
- No obvious abnormal occlusal relationship (the corresponding relationship between the upper jaw and the lower jaw is not normal, and the chewing efficiency is low).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blinded, Parallel, Placebo-controlled Study to Investigate the Efficacy of Lb Rhamnosus [Junlebao Lr. X253] as Oral Probiotics
The aim of the study is to study the application of Lactobacillus rhamnosus X253 as oral probiotics by the way of a randomised, double blinded, parallel, placebo-controlled clinical trial, and to eto detect the changes in oral flora of volunteers, and judge the improvement effect of X253 lozenges on the human oral flora.
Read the detailed description
population experiments were carried out, and Quantitative Real-time PCR was used to detect the expression level of the target strains in volunteers' oral, High-throughput sequencing technology to detect the changes in oral flora of volunteers, and judge the improvement effect of X253 lozenges on the human oral flora. The effects of X253 lozenges on the volunteers' oral odor, defecation frequency and gum bleeding was surveyed and conuted by questionnaire.
- Conditions
- Dental Caries
- Being tested
- Lactobacillus rhamnosus X253
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus rhamnosus X253Biological
Every two weeks, all volunteers were given the number of probiotic lozenges to be used within two weeks. Edible method: 3 times a day, 1 tablet every time (0.8g/tablet). Put the tablet in the mouth and keep it in the mouth for at least 2-3 minutes before swallowing. Take it once every 30 minutes after breakfast, lunch and dinner. Do not brush your teeth, eat foods, or rinse your mouth within half an hour of consumption. Maintain oral hygiene according to the original habits during consumption, and do not use fluoride toothpaste during consumption.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | who met inclusion criteria, will receive an identical X253 Probiotic lozenge Supplement looking and tasting placebo. Receives: Biological: Lactobacillus rhamnosus X253 |
| Viable group | Experimental | who met inclusion criteria, will receive an identical X253 Probiotic lozenge(containing active L.r X253). Receives: Biological: Lactobacillus rhamnosus X253 |
| Inactivated group | Experimental | who met inclusion criteria, will receive an identical X253 Probiotic lozenge(containing inactive L.r X253). Receives: Biological: Lactobacillus rhamnosus X253 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Porphyromonas gingivalis(P.g), Streptococcus mutans(S.m), Streptococcus gordonii(S.g), and Bifidobacterium(Bif) gene expression from tartar samples
In a sterile operating table, place the collected dental floss in a 180μL lysozyme (20mg/mL) water bath, use a DNA extraction kit (Tiangen Biotechnology Co., Ltd.) to extract the DNA in the oral sample, and store the DNA sample at -20°C. Quantitative Real-time PCR (Tiangen Biotechnology Co., Ltd.) was performed for the Porphyromonas gingivalis(P.g), Streptococcus mutans(S.m), Streptococcus gordonii(S.g), and Bifidobacterium(Bif) contained in the DNA of the tartar sample. The experiment results at 0 weeks were used as the control, and the relative quantitative method which is named 2-∆∆ct method was used to calculate the gene expression level of the target bacteria in the 2th week.
Measured: week 2 during the intervention
Porphyromonas gingivalis(P.g), Streptococcus mutans(S.m), Streptococcus gordonii(S.g), and Bifidobacterium(Bif) gene expression from tartar samples
In a sterile operating table, place the collected dental floss in a 180μL lysozyme (20mg/mL) water bath, use a DNA extraction kit (Tiangen Biotechnology Co., Ltd.) to extract the DNA in the oral sample, and store the DNA sample at -20°C. Quantitative Real-time PCR (Tiangen Biotechnology Co., Ltd.) was performed for the Porphyromonas gingivalis(P.g), Streptococcus mutans(S.m), Streptococcus gordonii(S.g), and Bifidobacterium(Bif) contained in the DNA of the tartar sample. The experiment results at 0 weeks were used as the control, and the relative quantitative method which is named 2-∆∆ct method was used to calculate the gene expression level of the target bacteria in the 4th week.
Measured: week 4 during the intervention
Secondary outcomes (1)
changes of oral problems
Design a questionnaire about the improvement of oral problems, and distribute it to the volunteers every week, then collect and organize the data.
Measured: 1 week during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start1 Nov 2020
- Primary completion14 Feb 2021
- Study completion2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 60 volunteers were recruited and randomly divided into three groups with 20 people in each group. Among them, 17 volunteers terminated the experiment due to taking antibiotics and hormone drugs during the experiment. The remaining 43 volunteers belonged to three different groups: Control group (n=16), Viable group (n=13), Inactivated group (n=14).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Junlebao Dairy Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123651
- Sponsor's protocol ID
- L.r X253 as oral probiotics
- Status last verified
- Nov 2021
- First submitted
- 18 Oct 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Parallel, Placebo-controlled Study to Investigate the Efficacy of Lb Rhamnosus [Junlebao Lr. X253] as Oral Probiotics
- ClinicalTrials.gov ID
- NCT05123651
- Acronym / sponsor ID
- L.r X253 as oral probiotics
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Junlebao Dairy Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 14 Feb 2021 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 17 Nov 2021 (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.
The aim of the study is to study the application of Lactobacillus rhamnosus X253 as oral probiotics by the way of a randomised, double blinded, parallel, placebo-controlled clinical trial, and to eto detect the changes in oral flora of volunteers, and judge the improvement effect of X253 lozenges on the human oral flora.
Detailed description
population experiments were carried out, and Quantitative Real-time PCR was used to detect the expression level of the target strains in volunteers' oral, High-throughput sequencing technology to detect the changes in oral flora of volunteers, and judge the improvement effect of X253 lozenges on the human oral flora. The effects of X253 lozenges on the volunteers' oral odor, defecation frequency and gum bleeding was surveyed and conuted by questionnaire.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A total of 60 volunteers were recruited and randomly divided into three groups with 20 people in each group. Among them, 17 volunteers terminated the experiment due to taking antibiotics and hormone drugs during the experiment. The remaining 43 volunteers belonged to three different groups: Control group (n=16), Viable group (n=13), Inactivated group (n=14).
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Biological: Lactobacillus rhamnosus X253who met inclusion criteria, will receive an identical X253 Probiotic lozenge Supplement looking and tasting placebo. |
| Viable group | Experimental | Biological: Lactobacillus rhamnosus X253who met inclusion criteria, will receive an identical X253 Probiotic lozenge(containing active L.r X253). |
| Inactivated group | Experimental | Biological: Lactobacillus rhamnosus X253who met inclusion criteria, will receive an identical X253 Probiotic lozenge(containing inactive L.r X253). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 rhamnosus X253Every two weeks, all volunteers were given the number of probiotic lozenges to be used within two weeks. Edible method: 3 times a day, 1 tablet every time (0.8g/tablet). Put the tablet in the mouth and keep it in the mouth for at least 2-3 minutes before swallowing. Take it once every 30 minutes after breakfast, lunch and dinner. Do not brush your teeth, eat foods, or rinse your mouth within half an hour of consumption. Maintain oral hygiene according to the original habits during consumption, and do not use fluoride toothpaste during consumption. | Biological | Control group, Inactivated group, Viable group |
Primary outcome
Porphyromonas gingivalis(P.g), Streptococcus mutans(S.m), Streptococcus gordonii(S.g), and Bifidobacterium(Bif) gene expression from tartar samples
Time frame: week 2 during the intervention
In a sterile operating table, place the collected dental floss in a 180μL lysozyme (20mg/mL) water bath, use a DNA extraction kit (Tiangen Biotechnology Co., Ltd.) to extract the DNA in the oral sample, and store the DNA sample at -20°C. Quantitative Real-time PCR (Tiangen Biotechnology Co., Ltd.) was performed for the Porphyromonas gingivalis(P.g), Streptococcus mutans(S.m), Streptococcus gordonii(S.g), and Bifidobacterium(Bif) contained in the DNA of the tartar sample. The experiment results at 0 weeks were used as the control, and the relative quantitative method which is named 2-∆∆ct method was used to calculate the gene expression level of the target bacteria in the 2th week.
Porphyromonas gingivalis(P.g), Streptococcus mutans(S.m), Streptococcus gordonii(S.g), and Bifidobacterium(Bif) gene expression from tartar samples
Time frame: week 4 during the intervention
In a sterile operating table, place the collected dental floss in a 180μL lysozyme (20mg/mL) water bath, use a DNA extraction kit (Tiangen Biotechnology Co., Ltd.) to extract the DNA in the oral sample, and store the DNA sample at -20°C. Quantitative Real-time PCR (Tiangen Biotechnology Co., Ltd.) was performed for the Porphyromonas gingivalis(P.g), Streptococcus mutans(S.m), Streptococcus gordonii(S.g), and Bifidobacterium(Bif) contained in the DNA of the tartar sample. The experiment results at 0 weeks were used as the control, and the relative quantitative method which is named 2-∆∆ct method was used to calculate the gene expression level of the target bacteria in the 4th week.
1 secondary outcome
changes of oral problems
Time frame: 1 week during the intervention
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 17 Nov 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 rhamnosus X253 in people with Dental Caries, run by Junlebao Dairy Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 17 Nov 2021. 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 China. 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?
Porphyromonas gingivalis(P.g), Streptococcus mutans(S.m), Streptococcus gordonii(S.g), and Bifidobacterium(Bif) gene expression from tartar samples (time frame: week 2 during the intervention). The study lists 2 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 17 Nov 2021.