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OpenTrials
Completed

NCT Number: NCT04289337

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.

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Key information

Conditions

Probiotics Oral Health Probiotic Metabolites

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glac Biotech Co., Ltd

Tainan, 802, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Combined probiotics (1)

Dietary Supplement

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

Combined probiotics (2)

Dietary Supplement

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

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 (2)

Dietary Supplement

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

Probiotic metabolites

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. The change from baseline colony-forming unit (CFU) of Streptococcus mutans at 4 weeks.

    Time frame: 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.

  2. The change from baseline concentration of saliva immunoglobulin A (IgA) at 4 weeks.

    Time frame: 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).

  3. The change from baseline microbiota at 4 weeks.

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Glac Biotech Co., Ltd

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 28, 2020
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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