Effectiveness and Safety of Probiotics in Protecting Liver Function

Not Applicable

Recruiting

• Conditions: Alcohol Abuse

• Registration Number: NCT06607562
• Lead Sponsor: Wecare Probiotics Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06-03
• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-18
• Last Update Submitted: 2024-09-18
• Study First Posted: 2024-09-23
• Last Update Posted: 2024-09-23
• Primary Completion: 2024-12-15
• Study Completion: 2025-04-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
liver function changes	56 days	To evaluate its effects on liver function in patients with alcohol-induced liver injury, with a primary focus on alanine aminotransferase (ALT) levels.

Trial Locations

Locations (1)

Wu Ying; 🇨🇳 Luoyang, Henan, China