Effectiveness and Safety of Probiotics in Protecting Liver Function

Not Applicable

Recruiting

• Conditions: Alcohol Abuse
• Interventions: Dietary Supplement: Probiotic group; Dietary Supplement: Placebo group

• 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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics group	Probiotic group	10B CFU/Sachet/Day BC99 before meals; Storage: Store in cool and dry place without sun exposure.
Placebo	Placebo group	Maltodextrin one Sachet/Day before meals; Storage: Store in cool and dry place without sun exposure.

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