Research on the Characteristics and Application of Lactobacillus Rhamnosus X253 as Oral Probiotics

Dental Caries Clinical Trial

Official title:

A Randomized, Double-blinded, Parallel, Placebo-controlled Study to Investigate the Efficacy of Lb Rhamnosus [Junlebao Lr. X253] as Oral Probiotics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05123651
• Other study ID #: L.r X253 as oral probiotics
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: March 2, 2021

Study information

• Verified date: November 2021
• Source: Shijiazhuang Junlebao Dairy Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 flora.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2, 2021
• Est. primary completion date: February 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

1. Age: 18 years old and above;

2. Gender: There is no restriction on men or women (women are not pregnant);

3. Keep more than 20 original teeth in the oral cavity;

4. Have not had periodontal treatment, tooth whitening (ceramic veneer, cold light whitening), orthodontics, etc. in the past 6 months;

5. No oral topical medication (such as mouthwash, watermelon frost) within 1 month;

6. No dental filling plan in the next 2-6 weeks;

7. 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;

8. 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).

Related Conditions & MeSH terms

• Dental Caries

Intervention

Biological:
• Lactobacillus rhamnosus X253
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.

Locations

Country	Name	City	State
China	Shijiazhuang JunlebaoDairy Co.Ltd.	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Shijiazhuang Junlebao Dairy Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	week 2 during the intervention
Primary	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.	week 4 during the intervention
Secondary	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.	1 week during the intervention