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

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.

Study Overview

• Status: Completed
• Conditions: Probiotics; Oral Health; Probiotic Metabolites
• Intervention / Treatment: Dietary supplement: Combined probiotics (1); Dietary supplement: Combined probiotics (2); Dietary supplement: Combined heat-killed probiotics (1); Dietary supplement: Combined heat-killed probiotics (2); Dietary supplement: Probiotic metabolites; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan City, Taiwan, 802
    • Glac Biotech Co., Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Combined probiotics (1); Combined Lactobacillus salivarius subsp. salicinius AP-32, Bifidobacterium animalis subsp. lactis CP-9 and Lactobacillus paracasei ET-66.	Dietary supplement: Combined probiotics (1); Subjects used one oral combined probiotics (1) tablet each morning, noon, and evening for 4 weeks.
EXPERIMENTAL: Combined probiotics (2); Combined Lactobacillus salivarius subsp. salicinius AP-32, Lactobacillus plantarum LPL28 and Lactobacillus paracasei ET-66.	Dietary supplement: Combined probiotics (2); Subjects used one oral combined probiotics (2) tablet each morning, noon, and evening for 4 weeks.
EXPERIMENTAL: 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.	Dietary supplement: Combined heat-killed probiotics (1); Subjects used one oral combined heat-killed probiotics (1) tablet each morning, noon, and evening for 4 weeks.
EXPERIMENTAL: Combined heat-killed probiotics (2); Combined heat-killed Lactobacillus salivarius subsp. salicinius AP-32 and Lactobacillus paracasei ET-66.	Dietary supplement: Combined heat-killed probiotics (2); Subjects used one oral combined heat-killed probiotics (2) tablet each morning, noon, and evening for 4 weeks.
EXPERIMENTAL: Probiotic metabolites; Combined Lactobacillus salivarius subsp. salicinius AP-32, Lactobacillus plantarum LPL28 and Lactobacillus paracasei ET-66 metabolites.	Dietary supplement: Probiotic metabolites; Subjects used one oral probiotic metabolites tablet each morning, noon, and evening for 4 weeks.
PLACEBO_COMPARATOR: Placebo; Does not contain probiotics, heat-killed probiotics and related metabolites.	Dietary supplement: Placebo; Subjects used one oral placebo tablet each morning, noon, and evening for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Glac Biotech Co., Ltd
• Investigators: Principal Investigator: Hsieh-Hsun Ho, Ph.D., Glac Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 21, 2019
• Primary Completion (ACTUAL): December 2, 2019
• Study Completion (ACTUAL): December 6, 2019

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: February 26, 2020
• First Posted (ACTUAL): February 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 26, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CS19052

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No