Effectiveness and Safety of Probiotics in Protecting Liver Function

Wecare Probiotics

Status: Enrolling

Conditions: Alcohol Abuse

Treatments: Dietary Supplement: Placebo group; Dietary Supplement: Probiotic group

Study type: Interventional

Funder types: Industry

Identifiers

NCT06607562

WK2024012

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups, including a placebo group

Probiotics group

Experimental group

Description:

10B CFU/Sachet/Day BC99 before meals; Storage: Store in cool and dry place without sun exposure.

Treatment:

Dietary Supplement: Probiotic group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo group