Alcohol Abuse
Conditions
Brief summary
To evaluate the effectiveness and safety of using probiotics to protect the liver function of long-term alcohol consumers
Interventions
DIETARY_SUPPLEMENTProbiotic group
Participants received Weizmannia coagulans BC99 supplementation for 60 days. Liver function indicators were assessed before and after intervention.
DIETARY_SUPPLEMENTPlacebo group
Participants received maltodextrin placebo for 60 days. Liver function indicators were assessed before and after intervention.
Sponsors
Wecare Probiotics Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in serum ALT, AST, γ-GT, and total bilirubin (TBil) levels | 60 days | Change from baseline to Day 60 in serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (γ-GT), and total bilirubin (TBil), measured using an automated biochemical analyzer. |
Countries
China
Contacts
STUDY_CHAIRYing Wu, Dr.
Henan University of Science and Technology
Outcome results
None listed