Novel Therapies in Moderately Severe Acute Alcoholic Hepatitis (NTAH-Mod)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01922895|
Recruitment Status : Recruiting
First Posted : August 14, 2013
Last Update Posted : May 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Alcoholic Hepatitis||Dietary Supplement: Lactobacillus Rhamnosus GG Drug: Placebo for Probiotic||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Novel Therapies in Moderately Severe Acute Alcoholic Hepatitis|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|