Clinical Trial: Novel Therapies in Moderately Severe Acute Alcoholic Hepatitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Novel Therapies in Moderately Severe Acute Alcoholic Hepatitis

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: University of Texas Southwestern Medical Center

Current Primary Outcome: MELD score [ Time Frame: 30 days ]

MELD scoring system for assessing the severity of chronic liver disease; MELD = 3.8[Ln serum bilirubin (mg/dL)] + 11.2[Ln INR] + 9.6[Ln serum creatinine (mg/dL)] + 6.4.


Original Primary Outcome: Same as current

Current Secondary Outcome: MELD score [ Time Frame: 180 days ]

Improvement in MELD score over 180 day study duration.


Original Secondary Outcome: Same as current

Information By: University of Texas Southwestern Medical Center

Dates:
Date Received: August 12, 2013
Date Started: October 2013
Date Completion: August 2018
Last Updated: May 10, 2017
Last Verified: May 2017