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

NCT04289337 | Completed

• 1 other identifier: CS19052
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Probiotics; Oral Health; Probiotic Metabolites

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• The change from baseline CFU of total oral microbiota at 4 weeks.

  4 weeks.

• The change from baseline CFU of probiotics at 4 weeks.

  4 weeks.

Study Arms (6)

Combined probiotics (1)

EXPERIMENTAL

Combined Lactobacillus salivarius subsp. salicinius AP-32, Bifidobacterium animalis subsp. lactis CP-9 and Lactobacillus paracasei ET-66.

Dietary Supplement: Combined probiotics (1)

Combined probiotics (2)

EXPERIMENTAL

Combined Lactobacillus salivarius subsp. salicinius AP-32, Lactobacillus plantarum LPL28 and Lactobacillus paracasei ET-66.

Dietary Supplement: Combined probiotics (2)

Combined heat-killed probiotics (1)

EXPERIMENTAL

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)

Combined heat-killed probiotics (2)

EXPERIMENTAL

Combined heat-killed Lactobacillus salivarius subsp. salicinius AP-32 and Lactobacillus paracasei ET-66.

Dietary Supplement: Combined heat-killed probiotics (2)

Probiotic metabolites

EXPERIMENTAL

Combined Lactobacillus salivarius subsp. salicinius AP-32, Lactobacillus plantarum LPL28 and Lactobacillus paracasei ET-66 metabolites.

Dietary Supplement: Probiotic metabolites

Placebo

PLACEBO COMPARATOR

Does not contain probiotics, heat-killed probiotics and related metabolites.

Dietary Supplement: Placebo

Interventions

Combined probiotics (1) DIETARY_SUPPLEMENT

Subjects used one oral combined probiotics (1) tablet each morning, noon, and evening for 4 weeks.

Combined probiotics (1)

Combined probiotics (2) DIETARY_SUPPLEMENT

Subjects used one oral combined probiotics (2) tablet each morning, noon, and evening for 4 weeks.

Combined probiotics (2)

Combined heat-killed probiotics (1) DIETARY_SUPPLEMENT

Subjects used one oral combined heat-killed probiotics (1) tablet each morning, noon, and evening for 4 weeks.

Combined heat-killed probiotics (1)

Combined heat-killed probiotics (2) DIETARY_SUPPLEMENT

Subjects used one oral combined heat-killed probiotics (2) tablet each morning, noon, and evening for 4 weeks.

Combined heat-killed probiotics (2)

Probiotic metabolites DIETARY_SUPPLEMENT

Subjects used one oral probiotic metabolites tablet each morning, noon, and evening for 4 weeks.

Probiotic metabolites

Placebo DIETARY_SUPPLEMENT

Subjects used one oral placebo tablet each morning, noon, and evening for 4 weeks.

Placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults between 20 to 40 years old.
• More than 10\^5 Streptococcus mutans (CFU/mL) of saliva.

You may not qualify if:

• Smoking.
• Subject has major illness.

Sponsors & Collaborators

• Glac Biotech Co., Ltd: lead

Study Sites (1)

Glac Biotech Co., Ltd

Tainan, 802, Taiwan

Location

Study Officials

• Hsieh-Hsun Ho, Ph.D.

  Glac Biotech Co., Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: R.D. Manager Doctor

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 28, 2020
• Study Start: October 21, 2019
• Primary Completion: December 2, 2019
• Study Completion: December 6, 2019
• Last Updated: February 28, 2020

Record last verified: 2020-02

Locations

TW (1)