Actively Recruiting
Protective Effect of Probiotics BC99 on Liver Function in Long-Term Alcohol Consumers: A Randomized, Double-Blind, Placebo-Controlled Trial
Led by Wecare Probiotics Co., Ltd. · Updated on 2024-09-23
80
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of probiotics in protecting liver function among people who have consumed alcohol heavily over a long period. The study focuses on adults aged 19 to 65 who have a history of consuming at least 40 grams of ethanol daily for over one year. The goal is to understand how probiotics might help maintain liver health in this group. Participants will be randomly assigned to one of two groups: one group will receive a daily sachet of probiotics (10 billion CFU BC99) before meals, while the other group will receive a placebo sachet containing maltodextrin, also taken daily before meals. Both products are stored in a cool, dry place away from sunlight. The experimental phase lasts 56 days, during which liver function, including alanine aminotransferase (ALT) levels, will be measured at the beginning and end of the study. During the 56-day study, participants will be monitored for changes in liver function through laboratory tests. They will follow the study protocol and restrictions, including using effective contraception if applicable, and complete follow-up visits to assess treatment adherence and safety. The main outcome measured is the change in liver function over the 56 days. Participants' overall health and study compliance will be observed to evaluate the probiotics' potential protective effects on the liver.
CONDITIONS
Brief Title
Effectiveness and Safety of Probiotics in Protecting Liver Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of long-term heavy alcohol consumption, equivalent to at least 40 grams of ethanol per day for over 1 year
- Body Mass Index (BMI) between 18 kg/m² and 25 kg/m²
- Voluntarily signed informed consent to participate in the study
- Agreement to follow the study protocol and restrictions
- No plans for conception from 14 days before screening until 6 months after study end; agreement to use effective contraception
You will not qualify if you...
- Having viral hepatitis, autoimmune liver disease, drug-induced liver damage, vascular liver disease, genetic metabolic liver disease, or primary liver cancer
- Recent use of substances similar to the tested product that might affect results
- Severe allergies or immune deficiencies
- Pregnant, breastfeeding, or planning pregnancy
- Severe diseases of vital organs including cardiovascular, lung, liver, kidney diseases, diabetes, severe thyroid disorders, metabolic diseases, malignant tumors, or severe immune system disorders
- Antibiotic use within the past two weeks
- Non-compliance with product consumption or follow-up visits
- Any condition deemed unsuitable by the researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 56 days
Participants take either the probiotic BC99 or a placebo daily before meals to assess their effects on liver function.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
Wu Ying
Luoyang, Henan, China, 471000
Actively Recruiting
Research Team
W
Wu yin, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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