NCT06899620CompletedNot Applicable
Weizmannia Coagulans BC179 Alleviates Post-Alcohol Discomfort May Via Taurine-Related Metabolism and Antioxidant Regulation: A Randomized, Double-Blind，Placebo-Controlled Trial
Wecare Probiotics Co., Ltd.2 sites in 1 country60 target enrollmentStarted: July 1, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Wecare Probiotics Co., Ltd.
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Effects of BC179 on alcohol metabolism
Study Overview
Brief Summary
To assess the effectiveness and safety of probiotic strain BC179 in reducing alcohol absorption in the gut, thereby lowering health risks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Inclusion Criteria:
- •Participants must be aged between 18 and 65 years.
- •They should have a documented history of long-term alcohol consumption, defined as consuming at least 20 grams of ethanol per day for at least one year. This is calculated using the formula: volume (mL) × alcohol content (%) × 0.
- •They must provide written informed consent and be willing to comply with the study procedures.
Exclusion Criteria
- •History of chronic liver, gastrointestinal, or systemic metabolic disorders.
- •Use of products with similar functions to the investigational formulation within the past two weeks.
- •Use of antibiotics, laxatives, or dietary supplements within the past four weeks.
- •Documented history of hypertension or diabetes.
- •Severe allergies or immune deficiencies.
- •Pregnancy, lactation, or planning pregnancy without effective contraception during the study period.
Arms & Interventions
Probiotic group
Experimental
10B CFU/Sachet/Day BC179 ; Storage: Store in cool and dry place without sun exposure
Intervention: Probiotic group (Dietary Supplement)
Placebo group
Placebo Comparator
Dextrin one Sachet/Day; Storage: Store in cool and dry place without sun exposure
Intervention: Placebo group (Dietary Supplement)
Outcomes
Primary Outcomes
Effects of BC179 on alcohol metabolism
Time Frame: 60 days
The impact of BC179 on alcohol metabolism is assessed by monitoring blood alcohol concentration (BAC) and related enzyme activities, such as alcohol dehydrogenase (ADH) and aldehyde dehydrogenase (ALDH).
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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