Evaluating SAMe for improving liver function in patients with alcoholic cirrhosis

A Multi-center, Randomized, Placebo-controlled Trial of S-Adenosylmethionine (SAMe) in Patients With Alcoholic Cirrhosis

This study is testing if a supplement called SAMe can help improve liver function in people with alcoholic cirrhosis.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 196 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Indiana University (Academic / other)
• Locations: 2 sites (Los Angeles, California and 1 other locations)
• Trial ID: NCT04250259 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled trial aims to assess the effects of S-adenosylmethionine (SAMe) on liver function in patients diagnosed with alcoholic cirrhosis classified as Child Class A or B. Participants will receive either SAMe or a placebo to determine if the supplement can improve liver function and reduce all-cause mortality. The study will include individuals aged 18 to 70 years, with specific inclusion and exclusion criteria to ensure appropriate patient selection. The primary objective is to establish a relationship between SAMe supplementation and liver health outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with alcoholic cirrhosis classified as Child Class A or B.

Not a fit: Patients with active infections or severe co-existing liver conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved liver function and reduced mortality rates in patients with alcoholic cirrhosis.

How similar studies have performed: Other studies have explored SAMe's effects on liver health, but this specific approach in alcoholic cirrhosis is relatively novel.

Eligibility criteria

Inclusion criteria for patients with alcoholic cirrhosis

1. 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
2. subjects with clinical presentation either in Child Class A or B at the time of enrollment
3. individuals 18 to 70 years old and may or may not consume alcohol during study.

Inclusion criteria for healthy control :

) individuals 18 to 70 years old (2) able to provide informed consent (3) subjects do not consume any alcohol or those who drink \< 50 grams per day on average in women and \< 80 grams per day on average in men (4) subjects are healthy without underlying acute or chronic medical conditions.

Exclusion criteria for patients with alcoholic cirrhosis

1. Active infection as evidenced by positive urine culture, blood culture, or pneumonia,
2. Known co-existing infection with hepatitis C, hepatitis B, or HIV
3. Significant systemic or major illness including chronic obstructive pulmonary disease, congestive heart failure, and renal failure that in the opinion of the Investigator would preclude the patient from participating in and completing the study
4. Gastrointestinal bleeding within the prior 28 days3
5. Participation in another investigational drug, biologic, or medical device trial within 30 days prior to screening
6. Women who are pregnant, may become pregnant, or nursing
7. Presence of any other disease or condition that is interfering with the absorption, distribution, metabolism, or excretion of SAMe such as those with gastric bypass surgery
8. Subjects with history of/diagnosis of hepatocellular carcinoma
9. Members from the same family of study participant. This is based on the recent paper on the non-random sampling in randomized controlled trials4. We acknowledge that if we assign family members to identical treatment, randomization would not be totally correct; but if properly randomized, there is a chance that the members of the family might mix the pills. To avoid this issue and maintain the integrity of randomized blinded fashion, we will not include members from the same family into the study
10. Subjects with psychiatric illnesses such as bipolar disorders as SAMe may interfere with the levels of anti-psychotic drugs and
11. Subjects who are immunocompromised

Exclusion criteria for all healthy control participants:

1. subjects with an active and serious medical disease
2. subjects with an infectious disease
3. consume any alcohol within 3 months before the study
4. subjects with localized or systemic infection

Where this trial is running

Los Angeles, California and 1 other locations

• Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
• Indiana University Hospital — Indianapolis, Indiana, United States (Recruiting)

Study contacts

• Principal investigator: Suthat Liangpunsakul, MD — Indiana University
• Study coordinator: Maggie Hesler, B.S

Conditions Alcoholic Cirrhosis; Child Class A or B