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

January 13, 2021 updated by: TCI Co., Ltd.
Investigating the possibility of using Bacillus coagulans TCI711 to improve the efficiency of alcohol removal in adult individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei City, Taiwan, 114
        • GeNext

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TCI711 probiotic
Taking one capsule (containing 10^10 of Bacillus coagulans TCI711) daily for one month
Dietary supplement: Bacillus coagulans TCI711
Using Bacillus coagulans TCI711 for one month and implementing alcohol testing at weeks 0, 1, and 4.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 minutes after drinking a certain volume of whisky
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.
15 minutes after drinking a certain volume of whisky
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.
30 minutes after drinking a certain volume of whisky
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.
60 minutes after drinking a certain volume of whisky
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.
90 minutes after drinking a certain volume of whisky
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.
120 minutes after drinking a certain volume of whisky
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.
150 minutes after drinking a certain volume of whisky
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.
180 minutes after drinking a certain volume of whisky

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TCI Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 13, 2020

Primary Completion (ACTUAL)

November 30, 2020

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

June 29, 2020

First Submitted That Met QC Criteria

July 2, 2020

First Posted (ACTUAL)

July 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 20-036-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breath Alcohol Level

Clinical Trials on Bacillus coagulans TCI711

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe