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

Not Applicable

Completed

• Conditions: Breath Alcohol Level
• Interventions: Dietary Supplement: Bacillus coagulans TCI711

• Registration Number: NCT04457661
• Lead Sponsor: TCI Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-07-02
• Study First Posted: 2020-07-07
• Study Start: 2020-07-13
• Primary Completion: 2020-11-30
• Study Completion: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TCI711 probiotic	Bacillus coagulans TCI711	Taking one capsule (containing 10\^10 of Bacillus coagulans TCI711) daily for one month

Primary Outcome Measures

Name	Time	Method
Breath Alcohol Level	180 minutes after drinking a certain volume of whisky	A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.

Trial Locations

Locations (1)

GeNext; 🇨🇳 Taipei City, Taiwan