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

NCT ID: NCT05123651

Last Updated: 2021-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2021-03-02

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Control group

who met inclusion criteria, will receive an identical X253 Probiotic lozenge Supplement looking and tasting placebo.

Group Type: PLACEBO_COMPARATOR

Lactobacillus rhamnosus X253

Intervention Type: BIOLOGICAL

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.

Viable group

who met inclusion criteria, will receive an identical X253 Probiotic lozenge(containing active L.r X253).

Group Type: EXPERIMENTAL

Lactobacillus rhamnosus X253

Intervention Type: BIOLOGICAL

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.

Inactivated group

who met inclusion criteria, will receive an identical X253 Probiotic lozenge(containing inactive L.r X253).

Group Type: EXPERIMENTAL

Lactobacillus rhamnosus X253

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Junlebao Dairy Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shijiazhuang JunlebaoDairy Co.Ltd.

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

L.r X253 as oral probiotics

Identifier Type: -

Identifier Source: org_study_id