This study is being done to find out whether a diet supplemented with a probiotic nutrient can improve alcoholic hepatitis and gut complications compared to routine standard care.
Aim 1: Evaluate the effects of probiotic supplements on improvement in MELD score and gut mucosal integrity in patients with MELD \< 21. Patients will be randomized to receive daily probiotics for 6 months and standard of care treatment or placebo with standard care. Aim 2: Document the natural history of moderately severe alcoholic hepatitis. Patients who decline randomization will be offered the option of inclusion in the study prospectively for data collection purposes and research study procedures. Aim 3: Create a data and tissue biorepository. This biorepository will serve as a national resource for studies related to acute alcoholic hepatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
45
Probiotic nutritional supplement; Lactobacillus Rhamnosus GG
Capsule manufactured without active ingredients.
University of Louisville
Louisville, Kentucky, United States
Cleveland Clinic
Cleveland, Ohio, United States
U Texas Southwestern Medical Center
Dallas, Texas, United States
MELD Score
Change in MELD scoring system for assessing the severity of chronic liver disease; MELD (Model of End Stage Liver Disease) scoring system for assessing the severity of chronic liver disease; calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) MELD = 3.8\[Ln serum bilirubin (mg/dL)\] + 11.2\[Ln INR\] + 9.6\[Ln serum creatinine (mg/dL)\] + 6.4. MELD score range from 6-40 with higher scores indicating more severe liver disease and a worse outcome.
Time frame: 30 days
MELD Score
Change in MELD scoring system over 180 day study duration. MELD (Model of End Stage Liver Disease) scoring system for assessing the severity of chronic liver disease; calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) MELD = 3.8\[Ln serum bilirubin (mg/dL)\] + 11.2\[Ln INR\] + 9.6\[Ln serum creatinine (mg/dL)\] + 6.4. MELD score range from 6-40 with higher scores indicating more severe liver disease and a worse outcome.
Time frame: 180 days
MELD Score
Change in MELD scoring system at 90 days study duration. MELD (Model of End Stage Liver Disease) scoring system for assessing the severity of chronic liver disease; calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) MELD = 3.8\[Ln serum bilirubin (mg/dL)\] + 11.2\[Ln INR\] + 9.6\[Ln serum creatinine (mg/dL)\] + 6.4. MELD score range from 6-40 with higher scores indicating more severe liver disease and a worse outcome.
Time frame: 90 days
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