Status:
RECRUITING
Effectiveness and Safety of Probiotics in Protecting Liver Function
Lead Sponsor:
Wecare Probiotics Co., Ltd.
Conditions:
Alcohol Abuse
Eligibility:
All Genders
19-65 years
Phase:
NA
Brief Summary
To evaluate the effectiveness and safety of using probiotics to protect the liver function of long-term alcohol consumers
Eligibility Criteria
Inclusion
- 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);
- Body Mass Index (BMI) between 18kg/m² and 25kg/m²;
- Voluntarily signed a written informed consent form, agreeing to participate in this study;
- Agreed to comply with the study protocol and restrictions;
- 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
- 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;
- Individuals who have recently consumed substances with similar functions to the tested product, potentially affecting the study results;
- Patients with severe allergies or immune deficiencies;
- Pregnant, breastfeeding, or women with plans for pregnancy;
- 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;
- Individuals who have used antibiotics within the past two weeks;
- Participants who did not comply with the required consumption of the tested product or missed follow-ups, making it impossible to evaluate the effectiveness;
- Other participants deemed unsuitable by the researchers.
Key Trial Info
Start Date :
June 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 15 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06607562
Start Date
June 3 2024
End Date
April 15 2025
Last Update
September 23 2024
Active Locations (1)
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1
Wu Ying
Luoyang, Henan, China, 471000