Novel Therapies in Moderately Severe Acute Alcoholic Hepatitis

Study ID

Cancer Related

Healthy Volunteers

Study Sites

  • Clements University Hospital
  • CTRC Outpatient
  • Parkland Health & Hospital System

Rosa Dehoyos

Principal Investigator
Mack Mitchell, M.D.

Official Title

Novel Therapies in Moderately Severe Acute Alcoholic Hepatitis

Brief Overview

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.

Participant Eligibility

Inclusion Criteria:

1. Ability to provide informed consent by subject or appropriate family member

2. Age between 21-70 years

3. Recent alcohol consumption > 50 g/d for > 6 months, continuing within two months
before enrollment

4. At least 2 of the following symptoms or signs of acute alcoholic hepatitis: Anorexia,
nausea, RUQ pain, jaundice, leukocytosis, hepatomegaly AND

5. Elevation of AST > 80 U/L, but < 500 U/L at the time of admission or within 3 days of
baseline visit; AST > ALT and ALT < 200 U/L; total bilirubin > 3 mg/dL AND

6. Liver biopsy showing alcoholic hepatitis (steatohepatitis) OR ultrasound of liver
showing increased echogenicity OR CT scan showing decreased attenuation of liver
compared to spleen OR MRI showing fatty liver (decreased signaling intensity on T1
weighted images). If the liver biopsy (done within 60 days of inclusion) confirms
diagnosis of AAH then inclusion e will be waived.

7. Model for End-Stage Liver Disease (MELD) <20

8. Willingness to utilize two reliable forms of contraception (both males and females of
childbearing potential) from screening through the first six weeks of study.

Exclusion Criteria:

1. Hypotension with BP < 80/50 after volume repletion

2. Pregnancy; incarceration; inability to provide consent or lack of appropriate family

3. Signs of systemic infection: Fever > 38o C and positive blood or ascites cultures on
appropriate antibiotic therapy for > 3 days within 3 days of inclusion

4. Acute gastrointestinal bleeding requiring > 2 units blood transfusion within the
previous 4 days

5. Undue risk from immunosuppression: Positive HBsAg; a positive skin PPD skin test or
history of treatment for tuberculosis; history of any malignancy including
hepatocellular carcinoma; known HIV infection

6. Treatment with corticosteroids or other immunosuppressive medications including
specific anti-TNF therapy (not including pentoxifylline), calcineurin inhibitors for
> 3 days within the previous 3 months.

7. Evidence of acute pancreatitis: CT evidence and/or amylase or lipase > 5 X upper
limit of normal

8. Serious cardiac, respiratory or neurologic disease or evidence of autoimmune
hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilsons
disease, hemochromatosis, secondary iron overload due to chronic hemolysis,
alpha-1-antitrypsin deficiency

9. Acute or chronic kidney injury with serum creatinine > 3.0 mg/dl