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Placebo

SAMe for Liver Cirrhosis

Phase 2

Recruiting

Led By Suthat Liangpunsakul, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

subjects are healthy without underlying acute or chronic medical conditions.

Evidence of cirrhosis as per clinical signs and/or noninvasive transient elastography (Fibroscan®), computed tomography, magnetic resonance imaging including MRI elastography compatible with cirrhosis and/or histopathology by biopsy and subjects with clinical presentation either in Child Class A or B at the time of enrollment

Must not have

Known co-existing infection with hepatitis C, hepatitis B, or HIV

Women who are pregnant, may become pregnant, or nursing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 24 months

Summary

This trial will test whether SAMe supplements can improve liver function in patients with alcoholic cirrhosis, which may lead to reduced all-cause mortality.

Who is the study for?

This trial is for adults aged 18-70 with alcoholic cirrhosis in Child Class A or B, who have been heavy drinkers but are now sober for at least 3 months. They must be generally healthy without serious illnesses like heart failure or infections and not on certain medications that affect SAMe's action.

What is being tested?

The study tests if a supplement called SAMe can improve liver function in patients with alcoholic cirrhosis compared to a placebo. Participants will randomly receive either the SAMe tablets or placebo, and researchers will monitor their liver health and overall survival.

What are the potential side effects?

While specific side effects of SAMe aren't detailed here, it may interact with psychiatric medications. Commonly reported side effects from other sources include digestive discomfort, dry mouth, headache, mild insomnia, and anxiety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am healthy with no serious long-term or sudden illnesses.

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I have cirrhosis confirmed by tests or biopsy and my condition is moderately severe.

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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have hepatitis C, hepatitis B, or HIV.

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I am not pregnant, at risk of becoming pregnant, or nursing.

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I have a condition affecting how my body handles medications, like having had gastric bypass surgery.

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I have been diagnosed with or have a history of liver cancer.

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I have used antibiotics or rifaximin for 10+ days in the last 2 months.

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I am younger than 18 or older than 70.

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I am unable to understand or sign the consent form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 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

SAMe supplement's effect on all-cause mortality

Secondary study objectives

SAMe supplement's effect on cellular oxidative stress and/or endoplasmic reticulum (ER) stress, as defined by mitochondrial DNA

SAMe supplement's effect on infections of the liver

SAMe supplement's effect on intestinal permeability function, as defined by serum lipopolysaccharides (LPS)

+6 more

Other study objectives

Exploratory outcome - identify who will improve their liver functions by taking the SAMe supplement amongst those that have been diagnosed with alcoholic cirrhosis (Child-Pugh score of A or B).

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: 1,200 mg SAMeExperimental Treatment1 Intervention

SAMe supplement (SAMe 400 mg tablet), 2 tablets in the morning before breakfast and one tablet in the evening before dinner (a total dose of 1,200 mg daily) for 24 months

Group II: Non-drinking ControlsActive Control1 Intervention

Non-drinking healthy controls

Group III: PlaceboPlacebo Group1 Intervention

Alcoholic Cirrhosis on placebo

0 / 10Eligibility criteria met