Probiotics for Alcoholic Liver Disease

Overseen By Tien Dong, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Antibiotics, Probiotics

Disqualifiers: Cirrhosis, Pancreatitis, Inflammatory bowel, others

Compensation: Varies

Number of Visits: 4

Duration: 6 months

80 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: Significant sex differences exist in regard to alcohol use disorder (AUD) and alcoholic liver disease (ALD). To date, no studies have examined the brain-gut-microbiome (BGM) axis (which is the relationship between the gut, brain, and the bacteria within the gut) and sex-differences in AUD and ALD. Aims: 1) Demonstrate baseline sex differences in the microbiome and metatranscriptome of AUD and ALD and correlate those differences to severity, 2) determine if these baseline sex differences predicts abstinence or ALD related outcomes, and 3) show how altering the microbiome can decrease the severity of AUD and ALD in a sexdependent manner. Hypothesis: Our project is aimed to explore the hypothesis that sex-related differences of the BGM axis in AUD and ALD explains the variation in patient severity and outcome by sex, and that alterations of the BGM axis can decrease the severity of AUD and ALD in a sex-dependent manner. Methods: A pilot randomized placebo (VSL#3 vs placebo) control trial will be performed in patients with AUD and ALD for 6 months. Questionnaire data, clinical labs, serum, and feces for shotgun metagenomics will be collected at baseline, 3-months, and 6-months. Anticipated Results: Patients with severe AUD/ALD will have more microbes and microbial genes associated with inflammation. These differences will predict outcomes at 6-months and that changes of this baseline microbiome with VSL#3 will lead to more positive outcomes than placebo, with men having greater benefit from VSL#3 than women. Implications and Future Studies: The discovery of the mechanisms underlying sex-related differences in AUD/ALD is needed for the development of personalized recommendations for prevention and treatment in men and women

Eligibility Criteria

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

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

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.

AUD will be defined based on the current DSM-V definition

Exclusion Criteria

I have never had inflammatory bowel disease, irritable bowel syndrome, any gastrointestinal cancer, or gastrointestinal surgery.

I have never had acute or chronic pancreatitis.

I haven't taken antibiotics in the last 3 months or probiotics in the last month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Collection of baseline data including questionnaire data, clinical labs, serum, and feces for shotgun metagenomics

1 week

1 visit (in-person)

Treatment

Participants are randomized to receive either VSL#3 or placebo for 6 months

6 months

3 visits (in-person) at baseline, 3 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• VSL #3 112.5 Capsule

Trial Overview 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.

Participant Groups

Group I: Probiotic Experimental Treatment 1 Intervention

VSL#3

Group II: Pacebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+