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

Not Applicable

Completed

• Conditions: Probiotics; Oral Health; Probiotic Metabolites
• Interventions: Dietary Supplement: Probiotic metabolites; Dietary Supplement: Combined probiotics (2); Dietary Supplement: Combined heat-killed probiotics (1); Dietary Supplement: Placebo; Dietary Supplement: Combined probiotics (1); Dietary Supplement: Combined heat-killed probiotics (2)

• Registration Number: NCT04289337
• Lead Sponsor: Glac Biotech Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-21
• Primary Completion: 2019-12-02
• Study Completion: 2019-12-06
• Status Verified: 2020-02
• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-02-26
• Last Update Submitted: 2020-02-26
• Study First Posted: 2020-02-28
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic metabolites	Probiotic metabolites	Combined Lactobacillus salivarius subsp. salicinius AP-32, Lactobacillus plantarum LPL28 and Lactobacillus paracasei ET-66 metabolites.
Combined probiotics (2)	Combined probiotics (2)	Combined Lactobacillus salivarius subsp. salicinius AP-32, Lactobacillus plantarum LPL28 and Lactobacillus paracasei ET-66.
Combined heat-killed probiotics (1)	Combined heat-killed probiotics (1)	Combined heat-killed Lactobacillus salivarius subsp. salicinius AP-32, Bifidobacterium animalis subsp. lactis CP-9 and Lactobacillus paracasei ET-66.
Placebo	Placebo	Does not contain probiotics, heat-killed probiotics and related metabolites.
Combined probiotics (1)	Combined probiotics (1)	Combined Lactobacillus salivarius subsp. salicinius AP-32, Bifidobacterium animalis subsp. lactis CP-9 and Lactobacillus paracasei ET-66.
Combined heat-killed probiotics (2)	Combined heat-killed probiotics (2)	Combined heat-killed Lactobacillus salivarius subsp. salicinius AP-32 and Lactobacillus paracasei ET-66.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Glac Biotech Co., Ltd; 🇨🇳 Tainan City, Taiwan