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

Not Applicable
Completed
Conditions
Dental Caries
Registration Number
NCT05123651
Lead Sponsor
Junlebao Dairy Group Co., Ltd.
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Porphyromonas gingivalis(P.g), Streptococcus mutans(S.m), Streptococcus gordonii(S.g), and Bifidobacterium(Bif) gene expression from tartar samplesweek 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.

Secondary Outcome Measures
NameTimeMethod
changes of oral problems1 week during the intervention

Design a questionnaire about the improvement of oral problems, and distribute it to the volunteers every week, then collect and organize the data.

Trial Locations

Locations (1)

Shijiazhuang JunlebaoDairy Co.Ltd.

🇨🇳

Shijiazhuang, Hebei, China

Shijiazhuang JunlebaoDairy Co.Ltd.
🇨🇳Shijiazhuang, Hebei, China

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