NCT01922895

Novel Therapies in Moderately Severe Acute Alcoholic Hepatitis

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Acute Alcoholic Hepatitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus Rhamnosus GG	Probiotic nutritional supplement; Lactobacillus Rhamnosus GG
DRUG	Placebo for Probiotic	Capsule manufactured without active ingredients.

Timeline

• Start date: 2013-08-01
• Primary completion: 2018-07-01
• Completion: 2021-08-31
• First posted: 2013-08-14
• Last updated: 2022-03-02
• Results posted: 2022-03-02

Locations

3 sites across 1 country: United States