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Effectiveness and Safety of Probiotics in Protecting Liver Function
RECRUITINGN/ASponsored by Wecare Probiotics Co., Ltd.
Actively Recruiting
PhaseN/A
SponsorWecare Probiotics Co., Ltd.
Started2024-06-03
Est. completion2024-12-15
Eligibility
Age19 Years – 65 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06607562
Summary
To evaluate the effectiveness and safety of using probiotics to protect the liver function of long-term alcohol consumers
Eligibility
Age: 19 Years – 65 YearsHealthy volunteers accepted
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; 3. Voluntarily signed a written informed consent form, agreeing to participate in this study; 4. Agreed to comply with the study protocol and restrictions; 5. 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.
Conditions2
Alcohol AbuseLiver Disease
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Actively Recruiting
PhaseN/A
SponsorWecare Probiotics Co., Ltd.
Started2024-06-03
Est. completion2024-12-15
Eligibility
Age19 Years – 65 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06607562