Effectiveness and Safety of Probiotics in Protecting Liver Function
Protective Effect of Probiotics BC99 on Liver Function in Long-Term Alcohol Consumers: A Randomized, Double-Blind, Placebo-Controlled Trial
Wecare Probiotics Co., Ltd.
80 participants
Jun 3, 2024
INTERVENTIONAL
Conditions
Summary
To evaluate the effectiveness and safety of using probiotics to protect the liver function of long-term alcohol consumers
Eligibility
Inclusion Criteria5
- 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 Criteria8
- 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.
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Interventions
The experimental phase of this study lasted for 56 days, during which we will measure participants' liver function, such as alanine aminotransferase (ALT) at baseline and end.
The experimental phase of this study lasted for 56 days, during which we will measure participants' liver function, such as alanine aminotransferase (ALT) at baseline and end.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06607562