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

NCT05123651 | Completed

• 1 other identifier: L.r X253 as oral probiotics
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• changes of oral problems

  1 week during the intervention

Study Arms (3)

Control group

PLACEBO COMPARATOR

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

Biological: Lactobacillus rhamnosus X253

Viable group

EXPERIMENTAL

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

Biological: Lactobacillus rhamnosus X253

Inactivated group

EXPERIMENTAL

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

Biological: Lactobacillus rhamnosus X253

Interventions

Lactobacillus rhamnosus X253 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.

Control group; Inactivated group; Viable group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Junlebao Dairy Group Co., Ltd.: lead

Study Sites (1)

Shijiazhuang JunlebaoDairy Co.Ltd.

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A total of 60 volunteers were recruited and randomly divided into three groups with 20 people in each group. Among them, 17 volunteers terminated the experiment due to taking antibiotics and hormone drugs during the experiment. The remaining 43 volunteers belonged to three different groups: Control group (n=16), Viable group (n=13), Inactivated group (n=14).

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 17, 2021
• Study Start: November 1, 2020
• Primary Completion: February 14, 2021
• Study Completion: March 2, 2021
• Last Updated: November 17, 2021

Record last verified: 2021-11

Locations

CN (1)