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RECRUITINGNA

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

NCT06607562•Wecare Probiotics Co., Ltd.

View on ClinicalTrials.gov

Summary

To evaluate the effectiveness and safety of using probiotics to protect the liver function of long-term alcohol consumers

Eligibility

Age

19 - 65 years

Sex

ALL

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.

Locations (1)

Wu Ying

Luoyang, Henan, China

Key Dates

Start Date

June 3, 2024

Primary Completion Date

December 15, 2024

Completion Date

April 15, 2025

Last Updated

September 23, 2024

Enrollment

ESTIMATED participants

Conditions

Alcohol Abuse

Interventions

Probiotic group

DIETARY_SUPPLEMENT

Placebo group

DIETARY_SUPPLEMENT

Contacts

Wu yin, Dr.

CONTACT

CN 18639283502 wuying2000@126.com

Effects of Tirzepatide on Alcohol Intake in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 23, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effectiveness and Safety of Probiotics in Protecting Liver Function

Inclusion Criteria

Exclusion Criteria

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