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OpenTrials
Completed

NCT Number: NCT06607562

Effectiveness and Safety of Probiotics in Protecting Liver Function

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

Completed

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Key information

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wu Ying

Luoyang, Henan, 471000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Probiotic group

Dietary Supplement

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

Placebo Group

Dietary Supplement

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

Primary outcomes

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

    Time frame: 60 days

    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.

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

The Improvement Effects of Weizmannia Coagulans BC99 on Liver Function and Gut Microbiota of Long-Term Alcohol Drinkers: A Randomized Double-Blind Clinical Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Sep 23, 2024
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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