Effectiveness and Safety of Probiotics in Protecting Liver Function

NCT06607562 | Recruiting

• 1 other identifier: WK2024012
• Study Type: interventional
• Target: 80
• 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)

• 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.

  56 days

Study Arms (2)

Probiotics group

EXPERIMENTAL

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

Dietary Supplement: Probiotic group

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo group

Interventions

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.

Probiotics group

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.

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

RECRUITING

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

Central Study Contacts

Wu yin, Dr.

CONTACT

CN 18639283502; wuying2000@126.com

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: December 15, 2024
• Study Completion: April 15, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)