Breath Alcohol LevelTCI711NCT04457661
Evaluation of the Alcohol Elimination Effect of TCI711 Probiotic (Bacillus Coagulans) on Adult Individuals
A study testing Bacillus coagulans TCI711 in people with Breath Alcohol Level, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
Investigating the possibility of using Bacillus coagulans TCI711 to improve the efficiency of alcohol removal in adult individuals. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Breath Alcohol Level
- What is being tested?
- Bacillus coagulans TCI711
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Jul 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Alcohol or drug allergy
- Liver, kidney, cardiovascular, or chronic diseases
- Other severe disorders
- Hypertension
- Pregnancy or lactation
- Already involved in clinical testing
- Other supplements
Trial locations and contacts
1 site in 1 country.
About this study
Investigating the possibility of using Bacillus coagulans TCI711 to improve the efficiency of alcohol removal in adult individuals.
- Conditions
- Breath Alcohol Level
- Being tested
- Bacillus coagulans TCI711
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacillus coagulans TCI711Dietary supplement
Using Bacillus coagulans TCI711 for one month and implementing alcohol testing at weeks 0, 1, and 4.
| Study group | Role | What they receive |
|---|---|---|
| TCI711 probiotic | Experimental | Taking one capsule (containing 10^10 of Bacillus coagulans TCI711) daily for one month Receives: Dietary Supplement: Bacillus coagulans TCI711 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath Alcohol Level
A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.
Measured: 5 minutes after drinking a certain volume of whisky
Breath Alcohol Level
A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.
Measured: 15 minutes after drinking a certain volume of whisky
Breath Alcohol Level
A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.
Measured: 30 minutes after drinking a certain volume of whisky
Breath Alcohol Level
A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.
Measured: 60 minutes after drinking a certain volume of whisky
Breath Alcohol Level
A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.
Measured: 90 minutes after drinking a certain volume of whisky
Breath Alcohol Level
A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.
Measured: 120 minutes after drinking a certain volume of whisky
Breath Alcohol Level
A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.
Measured: 150 minutes after drinking a certain volume of whisky
Breath Alcohol Level
A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.
Measured: 180 minutes after drinking a certain volume of whisky
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start13 Jul 2020
- Primary completion30 Nov 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breath Alcohol LevelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457661
- Sponsor's protocol ID
- 20-036-A
- Acronym
- TCI711
- Status last verified
- Jan 2021
- First submitted
- 29 Jun 2020
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Alcohol Elimination Effect of TCI711 Probiotic (Bacillus Coagulans) on Adult Individuals
- ClinicalTrials.gov ID
- NCT04457661
- Acronym / sponsor ID
- TCI711 / 20-036-A
- Conditions
- Breath Alcohol Level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigating the possibility of using Bacillus coagulans TCI711 to improve the efficiency of alcohol removal in adult individuals.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TCI711 probiotic | Experimental | Dietary Supplement: Bacillus coagulans TCI711Taking one capsule (containing 10^10 of Bacillus coagulans TCI711) daily for one month |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- Alcohol or drug allergy
- Liver, kidney, cardiovascular, or chronic diseases
- Other severe disorders
- Hypertension
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacillus coagulans TCI711Using Bacillus coagulans TCI711 for one month and implementing alcohol testing at weeks 0, 1, and 4. | Dietary supplement | TCI711 probiotic |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Breath Alcohol Level
Recruiting
Multi-Component Breath Alcohol Intervention Phase 3
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RecruitingObservational study
Towards a Wearable Alcohol Biosensor: Examining the Accuracy of BAC Estimates From New-Generation Transdermal Technology Using Large-Scale Human Testing and Machine Learning Algorithms
Alcohol Drinking, Alcohol Intoxication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bacillus coagulans TCI711 in people with Breath Alcohol Level, run by TCI Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breath Alcohol Level (time frame: 5 minutes after drinking a certain volume of whisky). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.