Novel Therapies in Moderately Severe Acute Alcoholic Hepatitis (NTAH-Mod)
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|ClinicalTrials.gov Identifier: NCT01922895|
Recruitment Status : Suspended (Lack of funding)
First Posted : August 14, 2013
Last Update Posted : November 4, 2020
|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)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Novel Therapies in Moderately Severe Acute Alcoholic Hepatitis|
|Actual Study Start Date :||August 2013|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||August 2023|
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
|United States, Kentucky|
|University of Louisville|
|Louisville, Kentucky, United States, 40202|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Texas|
|U Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Mack C Mitchell, M.D.||U Texas Southwestern Medical Center|