Effectiveness and Safety of Probiotics in Protecting Liver Function

Launched by WECARE PROBIOTICS CO., LTD. · Sep 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether probiotics, which are good bacteria that can help balance the gut, can protect the liver function of people who have been heavy alcohol drinkers for a long time. Researchers want to see if taking probiotics can help these individuals maintain better liver health. To participate, individuals need to have a history of drinking a significant amount of alcohol—about 40 grams or more per day—for over a year, and they should have a body mass index (BMI) between 18 and 25.

Participants will need to agree to follow the study's rules and provide informed consent, meaning they understand the study and are willing to take part. It's important to note that this study is not for everyone; people with certain liver diseases, severe allergies, or serious health conditions are excluded. Additionally, women who are pregnant or planning to become pregnant cannot participate. Those who qualify will have the opportunity to help researchers learn more about how probiotics might benefit liver health in heavy drinkers.

Gender

ALL

Eligibility 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;
• • 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.