VSL #3 112.5 Capsule for Liver Diseases, Alcoholic

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of California, Los Angeles, Los Angeles, CA
Liver Diseases, Alcoholic+6 More
VSL #3 112.5 Capsule - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a probiotic can improve outcomes for people with alcohol use disorder.

See full description

Eligible Conditions

  • Liver Diseases, Alcoholic
  • Alcohol Use Disorders (AUD)
  • severe alcoholic liver disease
  • Microbiome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Liver Diseases, Alcoholic

Study Objectives

This trial is evaluating whether VSL #3 112.5 Capsule will improve 1 primary outcome and 4 secondary outcomes in patients with Liver Diseases, Alcoholic. Measurement will happen over the course of Baseline to 6 months.

Baseline to 6 months
Alcohol Craving changes due to sex differences within ALD
Alcohol consumption changes due to sex differences within ALD
Microbiome changes due to sex differences within ALD
Quality of life changes due to sex differences within ALD
Sex differences within ALD

Trial Safety

Safety Progress

1 of 3

Other trials for Liver Diseases, Alcoholic

Trial Design

2 Treatment Groups

Probiotic
1 of 2
Pacebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 80 total participants across 2 different treatment groups

This trial involves 2 different treatments. VSL #3 112.5 Capsule is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Probiotic
Drug
VSL#3
Pacebo
Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to 6 months for reporting.

Who is running the study

Principal Investigator
T. S. D.
Tien S. Dong, MD
University of California, Los Angeles

Closest Location

University of California, Los Angeles - Los Angeles, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Liver Diseases, Alcoholic or one of the other 6 conditions listed above. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Adult patients admitted to Santa Monica UCLA hospital or Ronald Reagan UCLA Hospital with a diagnosis of AUD and ALD will be screened and potentially recruited.
ALD patients will be identified based on the recent American Association of the Study of Liver Disease (AASLD) guidelines: onset of jaundice within 8 weeks, 2) ongoing consumption of ethanol of >40 for women or >60 in men for 6 months or <60 days of abstinence before onset of jaundice, AST>50, AST:ALT>1.5 and both <400 IU/L, total bilirubin >3, or liver biopsy showing histologic features of ALD.
AUD will be defined based on the current DSM-V definition

Patient Q&A Section

How many people get liver diseases, alcoholic a year in the United States?

"Alcoholic liver diseases are among the most frequent co-morbidities of chronic alcoholic hepatitis in the United States. Alcoholic liver diseases constitute the most common cause of acute liver failure in US alcoholic patients, and are the leading cause of death among this population." - Anonymous Online Contributor

Unverified Answer

What are common treatments for liver diseases, alcoholic?

"Most patients with alcoholic liver disease require medical treatment. Because of the lack of good clinical trials, the optimal intervention is not entirely clear. The goal is to prolong survival and to minimize complications such as hepatocellular carcinoma.\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of liver diseases, alcoholic?

"Signs of alcoholic liver diseases are those listed in the table. They are typically related to problems of digestion and absorption. Those signs associated with liver disease and steatosis and cirrhosis are more likely to have no obvious cause but are more likely to be reversed. The signs listed in the table are those to look for in patients attending hospitals due to problems of digestion and absorption.\n- Liver biopsy\n1. Signs of liver disease: raised liver enzymes, elevated gamma glutamyl transpeptidase (GGT) and bilirubin.\n2." - Anonymous Online Contributor

Unverified Answer

What causes liver diseases, alcoholic?

"Alcoholism is one of the most important risk factors for chronic liver diseases. On the other hand, cirrhosis and hepatocellular carcinoma share a common genetic background. Further, it appears that a chronic infection by HBV in chronic alcoholic patients may lead to higher incidence of these lesions. Thus, this study shows that alcoholism causes liver diseases. However, the mechanism by which it causes liver damage is not yet clear at the epidemiological level." - Anonymous Online Contributor

Unverified Answer

What is liver diseases, alcoholic?

"Alcohol use can be a cause of alcoholic liver disease, because of chronic alcoholic hepatitis and cirrhosis. Alcohol can also exacerbate the course of alcohol-related liver diseases. The diagnosis and the early initiation of treatment are of great importance for the improvement of the outcome of alcoholic liver disease. Therefore, screening for cirrhosis and HBV at an early stage helps prevent progression and complications." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating liver diseases, alcoholic?

"The advances in research into alcoholic liver disease have led to progress in many pharmacologic and surgical alternatives for the treatment of this prevalent disease." - Anonymous Online Contributor

Unverified Answer

Is vsl #3 112.5 capsule typically used in combination with any other treatments?

"In the absence of data from randomized controlled trials, there is no basis for recommending specific prescribing practices of GVS-3 in combination with other treatments. The conclusions from this sub-analysis are based on individual patient data." - Anonymous Online Contributor

Unverified Answer

Is vsl #3 112.5 capsule safe for people?

"The safety and effectiveness profile for vsl capsule 112.5 in alcoholic men and post-menopausal women suggests that additional studies be conducted with this dose. The data also indicate that capsule 112.5 might have a role in the management of mild-to-moderate hepatic fibrosis." - Anonymous Online Contributor

Unverified Answer

How serious can liver diseases, alcoholic be?

"Moderate/severe alcoholic liver disease is a lethal condition. This is one of the most important determinants of mortality in patients with chronic alcohol abuse, and also in those who develop alcoholic hepatitis in the course of chronic alcohol abuse. Liver disease prevalence can be reduced by limiting alcohol in the population." - Anonymous Online Contributor

Unverified Answer

Does liver diseases, alcoholic run in families?

"Alcoholic liver disease is a common hereditary problem. To minimize the effect of familial alcohol consumption, the prevention plan of alcohol consumption ought to be strengthened. Patients are encouraged to detect early signs of liver diseases, such as asymptomatic hepatitis, and to get regular medical or dental check-ups." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of liver diseases, alcoholic?

"In South Korea, alcohol consumption predominates as the primary cause of liver diseases, especially alcoholic and viral causes. Alcohol-related liver diseases are the most important and potentially treatable diseases in general medicine." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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