Effectiveness and Safety of Probiotics in Protecting Liver Function

NCT06607562 | Completed

• 1 other identifier: WK2024012
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alcohol Abuse

Outcome Measures

Primary Outcomes (1)

• Change from baseline in serum ALT, AST, γ-GT, and total bilirubin (TBil) levels

  Change from baseline to Day 60 in serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (γ-GT), and total bilirubin (TBil), measured using an automated biochemical analyzer.

  60 days

Study Arms (2)

Probiotics group

EXPERIMENTAL

10B CFU/Sachet/Day Weizmannia coagulans BC99 Storage: Store in cool and dry place without sun exposure.

Dietary Supplement: Probiotic group

Placebo

PLACEBO COMPARATOR

Maltodextrin one Sachet/Day Storage: Store in cool and dry place without sun exposure.

Dietary Supplement: Placebo group

Interventions

Probiotic group DIETARY_SUPPLEMENT

Participants received Weizmannia coagulans BC99 supplementation for 60 days. Liver function indicators were assessed before and after intervention.

Probiotics group

Placebo group DIETARY_SUPPLEMENT

Participants received maltodextrin placebo for 60 days. Liver function indicators were assessed before and after intervention.

Placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• Body Mass Index (BMI) between 18kg/m² and 25kg/m²;
• Voluntarily signed a written informed consent form, agreeing to participate in this study;
• Agreed to comply with the study protocol and restrictions;
• 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.

You may not qualify if:

• 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;
• Individuals who have recently consumed substances with similar functions to the tested product, potentially affecting the study results;
• Patients with severe allergies or immune deficiencies;
• Pregnant, breastfeeding, or women with plans for pregnancy;
• 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;
• Individuals who have used antibiotics within the past two weeks;
• Participants who did not comply with the required consumption of the tested product or missed follow-ups, making it impossible to evaluate the effectiveness;
• Other participants deemed unsuitable by the researchers.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Wu Ying

Luoyang, Henan, 471000, China

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Ying Wu, Dr.

  Henan University of Science and Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 23, 2024
• Study Start: June 3, 2024
• Primary Completion: November 15, 2024
• Study Completion: November 1, 2025
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)