Novel Therapies in Moderately Severe Acute Alcoholic Hepatitis (NTAH-Mod)
|Acute Alcoholic Hepatitis||Dietary Supplement: Lactobacillus Rhamnosus GG Drug: Placebo for Probiotic|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
|Official Title:||Novel Therapies in Moderately Severe Acute Alcoholic Hepatitis|
- 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.
- MELD score [ Time Frame: 180 days ]Improvement in MELD score over 180 day study duration.
- Gut mucosal permeability [ Time Frame: 180 days ]Gut mucosal permeability will be measured by changes from baseline in the gut mucosal integrity as assessed by the lactulose/mannitol test.
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||August 2018|
|Estimated Primary Completion Date:||August 2018 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo for Probiotic
Placebo capsule that matches the probiotic capsule in appearance will be given once daily for 180 days.
Drug: Placebo for Probiotic
Capsule manufactured without active ingredients.
Other Name: Dummy capsule
Active Comparator: Lactobacillus Rhamnosus GG
Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.
Dietary Supplement: Lactobacillus Rhamnosus GG
Probiotic nutritional supplement; Lactobacillus Rhamnosus GG
Other Name: Culturelle
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01922895
|Contact: Mack C Mitchell, M.D.||214-645-8300||Mack.Mitchell@UTSouthwestern.edu|
|Contact: Blair Holbein, PhD||214-648-5009||Blair.Holbein@UTSouthwestern.edu|
|United States, Kentucky|
|University of Louisville||Recruiting|
|Louisville, Kentucky, United States, 40202|
|Contact: Craig J McClain, MD 502-852-6991|
|Principal Investigator: Craig J McClain, MD|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Arthur J McCullough, MD 216-444-2766|
|Principal Investigator: Arthur J McCullough, MD|
|United States, Texas|
|U Texas Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Mack C Mitchell, M.D. 214-645-8300 Mack.Mitchell@UTSouthwestern.edu|
|Principal Investigator: Mack C Mitchell, MD|
|Principal Investigator:||Mack C Mitchell, M.D.||U Texas Southwestern Medical Center|