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

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Biological: Lactobacillus rhamnosus X253

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Shijiazhuang JunlebaoDairy Co.Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; who met inclusion criteria, will receive an identical X253 Probiotic lozenge Supplement looking and tasting placebo.	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.
Experimental: Viable group; who met inclusion criteria, will receive an identical X253 Probiotic lozenge(containing active L.r X253).	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.
Experimental: Inactivated group; who met inclusion criteria, will receive an identical X253 Probiotic lozenge(containing inactive L.r X253).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shijiazhuang Junlebao Dairy Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): February 14, 2021
• Study Completion (Actual): March 2, 2021

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: November 9, 2021
• First Posted (Actual): November 17, 2021

Study Record Updates

• Last Update Posted (Actual): November 17, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: L.r X253 as oral probiotics

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No