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SAMe Trial for Patients with Alcoholic Cirrhosis

Phase 2
Recruiting
Conditions
Alcoholic Cirrhosis
Interventions
Registration Number
NCT04250259
Lead Sponsor
Indiana University
Brief Summary

The proposed of this randomized, double blinded, placebo-controlled study is to assess the effect of SAMe compared to placebo in patients with alcoholic cirrhosis Child Class A and B. The primary objective of the study is to test relationship between SAMe (S-adenosylmethionine) supplement on liver function. The hypothesis is that SAMe supplement will improve liver function in patients with alcoholic liver disease. The improvement in liver function will lead to the reduction in all-cause mortality in patients with alcoholic cirrhosis in those who receive SAMe supplement when compared to those receiving placebo.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
196
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboAlcoholic Cirrhosis on placebo
1,200 mg SAMeSAMe 400 mg tabletSAMe 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
Primary Outcome Measures
NameTimeMethod
SAMe supplement's effect on all-cause mortalityBaseline to end of 24 months

The hypothesis is that SAMe supplement will improve liver function in patients with alcoholic liver disease. The improvement in liver function will lead to the reduction in all-cause mortality in patients with alcoholic cirrhosis in those who receive SAMe supplement when compared to those receiving placebo.

Secondary Outcome Measures
NameTimeMethod
SAMe supplement's effect on intestinal permeability function, as defined by serum lipopolysaccharides (LPS)baseline to end of 24 months

The function of intestinal permeability will be evaluated by testing serum lipopolysaccharides (LPS) in patients who receive SAMe compared to those who receive placebo. Lipopolysaccharides (LPS) are large molecules consisting of a lipid and a polysaccharide that are bacterial toxins.

SAMe supplement's effect on cellular oxidative stress and/or endoplasmic reticulum (ER) stress, as defined by mitochondrial DNAbaseline to 24 months

Cellular oxidative stress and/or endoplasmic reticulum (ER) stress will be evaluated by measuring the levels of mitochondrial DNA in the blood of patients who receive SAMe compared to those who receive placebo.

SAMe supplement's effect on liver deuteriationbaseline to 24 months

determining Proportion of subjects undergoing liver transplantation in patients who receive SAMe compared to those who receive placebo

SAMe supplement's effect on liver developing cancerbaseline to 24 months

Proportion of subjects developing new onset hepatocellular carcinoma in patients who receive SAMe compared to those who receive placebo

SAMe supplement's effect on infections of the liverbaseline to 24 months

Proportion of subjects with infection/sepsis (other than SBP) in patients who receive SAMe compared to those who receive placebo

SAMe supplement's effect on other parts of the bodybaseline to 24 months

capture safety-related endpoints by determining proportion of patients with nausea and emesis, proportion of subjects with unexplained diarrhea in patients receive SAMe compared to those who receive placebo.

SAMe supplement's effects on intestinal permeability function, as defined by soluble(s) CD14baseline to 24 months

The function of intestinal permeability will be evaluated by testing soluble(s) CD14 in patients who receive SAMe compared to those who receive placebo. sCD14 either appears after shedding of mCD14 (48 kDa) or is directly secreted from intracellular vesicles (56 kDa).

SAMe supplement's effects on intestinal permeability function, as defined by soluble(s) CD163baseline to 24 months

The function of intestinal permeability will be evaluated by testing soluble(s) CD163 in patients who receive SAMe compared to those who receive placebo. CD163 is an endocytic receptor for haptoglobin-hemoglobin complexes and is expressed solely on macrophages and monocytes. As a result of ectodomain shedding, the extracellular portion of CD163 circulates in blood as a soluble protein (sCD163).

SAMe supplement's effects on cellular oxidative stress and/or endoplasmic reticulum (ER) stress, as defined by cytochrome P450 2E1 levelsbaseline to 24 months

Levels of cellular oxidative stress and/or endoplasmic reticulum (ER) stress will be evaluated by measuring the levels of cytochrome P450 2E1 (CYP2E1) enriched microparticles in patients who receive SAMe compared to those who receive placebo.CYP2E1 is a member of the cytochrome P450 mixed-function oxidase system, which is involved in the metabolism of xenobiotics in the body.

Trial Locations

Locations (2)

Cedars-Sinai Medical Center

🇺🇸

Los Angeles, California, United States

Indiana University Hospital

🇺🇸

Indianapolis, Indiana, United States

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