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Probiotic

Probiotics for Alcoholic Liver Disease

N/A
Recruiting
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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, 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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 months
Awards & highlights

Study Summary

This trial is looking at whether or not there are sex-related differences in the brain-gut-microbiome (BGM) axis in patients with alcohol use disorder (AUD) and alcoholic liver disease (ALD), and whether or not these differences predict abstinence or ALD related outcomes.

Who is the study for?
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.Check my eligibility
What is being tested?
The trial is testing if a probiotic capsule called VSL#3 can improve the gut microbiome and reduce severity of ALD and AUD compared to a placebo. It will also explore sex differences in treatment outcomes over a 6-month period using questionnaires and biological sample analyses.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of probiotics like VSL#3 may include digestive discomfort such as gas or bloating. Placebos typically have no active ingredients but can cause perceived side effects due to patient expectations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have liver disease with specific symptoms and history of heavy drinking.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sex differences within ALD
Secondary outcome measures
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
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ProbioticExperimental Treatment1 Intervention
VSL#3
Group II: PaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,525 Previous Clinical Trials
10,275,953 Total Patients Enrolled
16 Trials studying Alcoholism
3,706 Patients Enrolled for Alcoholism

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants can enroll in this experiment?

"Affirmative. According to data hosted on clinicaltrials.gov, this clinical trial first posted on January 31st 2022 is still actively recruiting patients - with 80 participants needed from one location thus far. The study was last updated on May 16th 2022."

Answered by AI

Are applications being currently accepted for this research endeavor?

"This experiment, with the initial post date of January 31st 2022 and most recent update on May 16th 2022 is actively searching for study participants according to information available on clinicaltrials.gov."

Answered by AI
Recent research and studies
~13 spots leftby Sep 2024