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NCT06899620 | NOT YET RECRUITING | Healthy

BC179 Against Alcohol-Induced Damage
Sponsor:

Wecare Probiotics Co., Ltd.

Brief Summary:

To assess the effectiveness and safety of probiotic strain BC179 in reducing alcohol absorption in the gut, thereby lowering health risks, as measured by participants' hangover scores.

Condition or disease

Healthy

Intervention/treatment

Probiotic group

Placebo group

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 80 participants
Masking : DOUBLE
Primary Purpose : OTHER
Official Title : Protective Effect of Probiotic BC179 on Alcohol-Induced Damage: A Randomized Trial
Actual Study Start Date : 2025-05-30
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2026-04-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
* Inclusion Criteria
  • 1. A history of long-term heavy alcohol consumption, equivalent to ethanol intake ≥40g/day for over 1 year. The conversion formula is: ethanol (g) = volume of ethanol-containing beverage (mL) × ethanol content (%) × 0.8 (specific gravity of ethanol);
  • 2. Body Mass Index (BMI) between 18kg/m² and 25kg/m²; Voluntarily signed a written informed consent form, agreeing to participate in this study;
  • 3. Agreed to comply with the study protocol and restrictions;
  • 4. Subjects (including male participants) have no plans for conception from 14 days prior to screening until 6 months after the end of the trial and voluntarily agree to use effective contraception.
  • * Exclusion Criteria
    • 1. Patients with various types of viral hepatitis, autoimmune liver disease, drug-induced liver damage, vascular liver disease, genetic metabolic liver disease, or primary liver cancer;
    • 2. Individuals who have recently consumed substances with similar functions to the tested product, potentially affecting the study results;
    • 3. Patients with severe allergies or immune deficiencies;
    • 4. Pregnant, breastfeeding, or women with plans for pregnancy;
    • 5. Individuals with severe diseases of vital organs such as cardiovascular, pulmonary, hepatic, renal conditions, or those with diabetes, severe thyroid disorders, metabolic diseases, malignant tumors, or severe immune system disorders;
    • 6. Individuals who have used antibiotics within the past two weeks;
    • 7. Participants who did not comply with the required consumption of the tested product or missed follow-ups, making it impossible to evaluate the effectiveness;
    • 8. Other participants deemed unsuitable by the researchers.
BC179 Against Alcohol-Induced Damage

Location Details

NCT06899620

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How to Participate

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Locations

Not yet recruiting

China, Henan

w u ying

Luoyang, Henan, China, 471000