Probiotics for Alcoholic Liver Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how probiotics might aid individuals with alcohol-related liver problems by examining the connection between the gut, brain, and gut bacteria. Researchers aim to determine if altering gut bacteria can reduce the severity of alcohol use disorder (AUD) and alcoholic liver disease (ALD), and whether these effects vary between men and women. Participants will receive either a probiotic treatment (VSL #3 112.5 Capsule) or a placebo for six months. Individuals diagnosed with AUD and ALD and currently receiving treatment at specific UCLA hospitals may be eligible to join. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatments for liver disease.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, you cannot have taken antibiotics within 3 months or probiotics within 1 month before joining the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that VSL#3, a mix of probiotics, is generally safe for people. Studies have found it can improve liver health and is well-tolerated by those with liver problems. In one study, participants with cirrhosis, a type of liver disease, who took VSL#3 experienced better nutrition and less severe liver disease without major side effects. Another study found that taking VSL#3 daily reduced hospital visits for liver issues over six months. Overall, evidence suggests that VSL#3 is safe and may help improve liver health.12345
Why are researchers excited about this trial?
Unlike the standard treatments for alcoholic liver disease, which often include medications like corticosteroids and lifestyle changes, VSL #3 is a probiotic that introduces beneficial bacteria to the gut. Researchers are excited because this approach targets gut health, potentially leading to improved liver function by reducing inflammation and bacterial translocation. This novel mechanism offers a promising alternative, focusing on restoring balance in the gut microbiome rather than directly targeting the liver itself.
What evidence suggests that this trial's treatments could be effective for alcoholic liver disease?
Research has shown that probiotics like VSL#3, which participants in this trial may receive, can improve liver function in individuals with alcoholic liver disease (ALD). One study found that VSL#3 significantly reduced the risk of hospital visits and improved key liver health scores over six months. Another study demonstrated that VSL#3 helped repair liver damage by correcting imbalances in gut bacteria. This probiotic appears to work by altering the gut microbiome, which is linked to liver health. Overall, VSL#3 shows promise in reducing the severity of liver disease symptoms.13678
Are You a Good Fit for This Trial?
Adults admitted to Santa Monica UCLA or Ronald Reagan UCLA Hospital with alcoholic liver disease (ALD) and alcohol use disorder (AUD), meeting specific medical criteria. Excluded are those recently on antibiotics or probiotics, with certain gastrointestinal conditions, advanced liver fibrosis, hepatic encephalopathy, or pancreatitis.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Collection of baseline data including questionnaire data, clinical labs, serum, and feces for shotgun metagenomics
Treatment
Participants are randomized to receive either VSL#3 or placebo for 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- VSL #3 112.5 Capsule
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor