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

Junlebao Dairy Group

Status: Completed

Conditions: Dental Caries

Treatments: Biological: Lactobacillus rhamnosus X253

Study type: Interventional

Funder types: Industry

Identifiers

NCT05123651

L.r X253 as oral probiotics

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

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

Treatment:

Biological: Lactobacillus rhamnosus X253

Viable group

Experimental group

Description:

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

Treatment:

Biological: Lactobacillus rhamnosus X253

Inactivated group

Experimental group

Description:

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

Treatment:

Biological: Lactobacillus rhamnosus X253