Effectiveness and Safety of Probiotics in Protecting Liver Function

NCT ID: NCT06607562

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-03
• Study Completion Date: 2025-04-15

Brief Summary

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

Conditions

Alcohol Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Probiotics group

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

Group Type: EXPERIMENTAL

Probiotic group

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Placebo group

Intervention Type: 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.

Interventions

Probiotic group

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo group

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ying Wu, Dr.

Role: STUDY_CHAIR

Henan University of Science and Technology

Locations

Wu Ying

Luoyang, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wu yin, Dr.

Role: CONTACT

wuying2000@126.com

CN 18639283502

Facility Contacts

Ying Wu, Dr.

Role: primary

wuying2000@126.com

18639283502

Other Identifiers

WK2024012

Identifier Type: -

Identifier Source: org_study_id