Using probiotics to protect liver function in heavy alcohol consumers

Protective Effect of Probiotics BC99 on Liver Function in Long-Term Alcohol Consumers: A Randomized, Double-Blind, Placebo-Controlled Trial

This study is testing if taking probiotics can help protect the liver in people who have a history of heavy drinking.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 19 Years to 65 Years
• Sex: All
• Sponsor: Wecare Probiotics Co., Ltd. (industry)
• Locations: 1 site (Luoyang, Henan)
• Trial ID: NCT06607562 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of probiotics in protecting liver function among individuals with a history of long-term heavy alcohol consumption. Participants will be divided into two groups: one receiving probiotics and the other receiving a placebo. The study aims to determine if probiotics can mitigate liver damage associated with alcohol abuse. Participants must meet specific criteria regarding alcohol intake and body mass index to qualify for the study.

Who should consider this trial

Good fit: Ideal candidates are individuals with a history of heavy alcohol consumption and a BMI between 18 and 25.

Not a fit: Patients with liver diseases such as viral hepatitis or autoimmune liver disease will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel approach to protecting liver health in individuals with alcohol abuse issues.

How similar studies have performed: While the use of probiotics for liver protection is a relatively novel approach, there have been some preliminary studies suggesting potential benefits, though this specific application is less tested.

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.

Where this trial is running

Luoyang, Henan

• Wu Ying — Luoyang, Henan, China (RECRUITING)

Study contacts

• Study coordinator: Wu yin, Dr.

Conditions: Alcohol Abuse