Double-blind Clinical Trials of Probiotic Products in Oral Health.

Oral Health Clinical Trial

Official title:

Double-blind Clinical Trials of Probiotic Products in Oral Health.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04289337
• Other study ID #: CS19052
• Status: Completed
• Phase: N/A
• Start date: October 21, 2019
• Est. completion date: December 6, 2019

Study information

• Verified date: February 2020
• Source: Glac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In order to evaluate the effects of supplementary probiotics and their metabolites on oral environment and oral microbiota, Taiwan FDA No. 88037803 will be used to evaluate the effects of oral probiotic candidate strains from previous research results and develop oral probiotic products.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 6, 2019
• Est. primary completion date: December 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Adults between 20 to 40 years old.

• More than 10^5 Streptococcus mutans (CFU/mL) of saliva.

Exclusion Criteria:

• Smoking.

• Subject has major illness.

Related Conditions & MeSH terms

• Oral Health
• Probiotic Metabolites
• Probiotics

Intervention

Dietary Supplement:
• Combined probiotics (1)
Subjects used one oral combined probiotics (1) tablet each morning, noon, and evening for 4 weeks.
• Combined probiotics (2)
Subjects used one oral combined probiotics (2) tablet each morning, noon, and evening for 4 weeks.
• Combined heat-killed probiotics (1)
Subjects used one oral combined heat-killed probiotics (1) tablet each morning, noon, and evening for 4 weeks.
• Combined heat-killed probiotics (2)
Subjects used one oral combined heat-killed probiotics (2) tablet each morning, noon, and evening for 4 weeks.
• Probiotic metabolites
Subjects used one oral probiotic metabolites tablet each morning, noon, and evening for 4 weeks.
• Placebo
Subjects used one oral placebo tablet each morning, noon, and evening for 4 weeks.

Locations

Country	Name	City	State
Taiwan	Glac Biotech Co., Ltd	Tainan City

Sponsors (1)

Lead Sponsor	Collaborator
Glac Biotech Co., Ltd

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from baseline colony-forming unit (CFU) of Streptococcus mutans at 4 weeks.	The plaque on the inside and outside of teeth was collected by cotton swab and putting in the microbial culture broth before and after taking the oral tablets. The microbial culture broth will be diluted and smeared on the mitis salivarius-bacitracin agar (MSBA) plate for counting the CFU of Streptococcus mutans.	4 weeks.
Primary	The change from baseline concentration of saliva immunoglobulin A (IgA) at 4 weeks.	The saliva was collected by the centrifuge tube before and after taking the oral tablets. IgA will be detected by enzyme-linked immunosorbent assay (ELISA).	4 weeks.
Primary	The change from baseline microbiota at 4 weeks.	The saliva was collected by the next-generation sequencing (NGS) saliva collection tube before and after taking the oral tablets. The changes in microbial flora will be detected by NGS.	4 weeks.
Secondary	The change from baseline CFU of total oral microbiota at 4 weeks.	The plaque on the inside and outside of teeth was collected by cotton swab and putting in the microbial culture broth before and after taking the oral tablets. The microbial culture broth will be diluted and smeared on the plate count agar (PCA) plate for counting the CFU of total oral microbiota.	4 weeks.
Secondary	The change from baseline CFU of probiotics at 4 weeks.	The plaque on the inside and outside of teeth was collected by cotton swab and putting in the microbial culture broth before and after taking the oral tablets. The microbial culture broth will be diluted and smeared on the De Man, Rogosa and Sharpe agar (MRSA) plate for counting the CFU of probiotics.	4 weeks.