Oral Health, Probiotic Metabolites, Probiotics
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTCombined probiotics (1)
Subjects used one oral combined probiotics (1) tablet each morning, noon, and evening for 4 weeks.
DIETARY_SUPPLEMENTCombined probiotics (2)
Subjects used one oral combined probiotics (2) tablet each morning, noon, and evening for 4 weeks.
DIETARY_SUPPLEMENTCombined heat-killed probiotics (1)
Subjects used one oral combined heat-killed probiotics (1) tablet each morning, noon, and evening for 4 weeks.
DIETARY_SUPPLEMENTCombined heat-killed probiotics (2)
Subjects used one oral combined heat-killed probiotics (2) tablet each morning, noon, and evening for 4 weeks.
DIETARY_SUPPLEMENTProbiotic metabolites
Subjects used one oral probiotic metabolites tablet each morning, noon, and evening for 4 weeks.
DIETARY_SUPPLEMENTPlacebo
Subjects used one oral placebo tablet each morning, noon, and evening for 4 weeks.
Sponsors
Glac Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change from baseline colony-forming unit (CFU) of Streptococcus mutans at 4 weeks. | 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. |
| The change from baseline concentration of saliva immunoglobulin A (IgA) at 4 weeks. | 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). |
| The change from baseline microbiota at 4 weeks. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change from baseline CFU of total oral microbiota at 4 weeks. | 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. |
| The change from baseline CFU of probiotics at 4 weeks. | 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. |
Countries
Taiwan
Outcome results
None listed