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OpenTrials
Completed

NCT Number: NCT04457661

Evaluation of the Alcohol Elimination Effect of TCI711 Probiotic (Bacillus Coagulans) on Adult Individuals

Investigating the possibility of using Bacillus coagulans TCI711 to improve the efficiency of alcohol removal in adult individuals.

Completed

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Key information

Conditions

Breath Alcohol Level

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GeNext

Taipei, 114, Taiwan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteers aged between 20 to 60.
  • Systolic pressure below 140
  • Score of C-CAGE Questionnaire below 8 (male)/6 (female)
  • Prohibiting other supplements before 2 weeks of the study and during the study
  • Prohibiting alcohol drinks before 24 hours of the study
  • Prohibiting caffeine drinks before 12 hours of the study

Exclusion criteria

  • Alcohol or drug allergy
  • Liver, kidney, cardiovascular, or chronic diseases
  • Other severe disorders
  • Hypertension
  • Pregnancy or lactation
  • Already involved in clinical testing
  • Other supplements

Treatment and study plan

Bacillus coagulans TCI711

Dietary Supplement

Using Bacillus coagulans TCI711 for one month and implementing alcohol testing at weeks 0, 1, and 4.

Primary outcomes

  1. Breath Alcohol Level

    Time frame: 5 minutes after drinking a certain volume of whisky

    A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.

  2. Breath Alcohol Level

    Time frame: 15 minutes after drinking a certain volume of whisky

    A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.

  3. Breath Alcohol Level

    Time frame: 30 minutes after drinking a certain volume of whisky

    A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.

  4. Breath Alcohol Level

    Time frame: 60 minutes after drinking a certain volume of whisky

    A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.

  5. Breath Alcohol Level

    Time frame: 90 minutes after drinking a certain volume of whisky

    A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.

  6. Breath Alcohol Level

    Time frame: 120 minutes after drinking a certain volume of whisky

    A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.

  7. Breath Alcohol Level

    Time frame: 150 minutes after drinking a certain volume of whisky

    A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.

  8. Breath Alcohol Level

    Time frame: 180 minutes after drinking a certain volume of whisky

    A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.

Sponsors and collaborators

Lead sponsor

TCI Co., Ltd.

Industry

Registry information

Acronym: TCI711

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 7, 2020
Registry last updated
Jan 15, 2021

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.