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Probiotic

Probiotics for Alcoholic Liver Disease

N/A
Waitlist Available
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
Must not have
Patients with a history of inflammatory bowel disease, irritable bowel syndrome, gastrointestinal malignancy, or gastrointestinal surgery will be excluded.
Patients with acute pancreatitis or a history of chronic pancreatitis will also be excluded. The diagnosis of acute pancreatitis and chronic pancreatitis will be ascertained from their history and physical.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 months

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.
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.
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
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I have liver disease with specific symptoms and history of heavy drinking.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never had inflammatory bowel disease, irritable bowel syndrome, any gastrointestinal cancer, or gastrointestinal surgery.
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I have never had acute or chronic pancreatitis.
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I do not have severe liver problems or confusion due to liver disease.
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If I start antibiotics during the study, I will be withdrawn to avoid affecting the study results.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sex differences within ALD
Secondary study objectives
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

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Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,564 Previous Clinical Trials
10,262,553 Total Patients Enrolled
20 Trials studying Alcoholism
4,249 Patients Enrolled for Alcoholism
~0 spots leftby Dec 2024
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