Effectiveness and Safety of Probiotics in Protecting Liver Function

ConditionAlcohol Abuse

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age19-65

SponsorWecare Probiotics Co., Ltd.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

Probiotic group
Dietary supplement
The experimental phase of this study lasted for 56 days, during which we will measure participants' liver function, such as alanine aminotransferase (ALT) at baseline and end.
Placebo group
Dietary supplement
The experimental phase of this study lasted for 56 days, during which we will measure participants' liver function, such as alanine aminotransferase (ALT) at baseline and end.

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Probiotics groupExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

liver function changes

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

Time frame

56 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wecare Probiotics Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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