NCT01922895|TerminatedResultsDMC
Study Stopped
Lack of funding
Novel Therapies in Moderately Severe Acute Alcoholic Hepatitis
NTAH-Mod
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Lack of funding
NTAH-Mod
Sponsor study identifier
Secondary identifiers
interventional
45
1 country
3
Study Start
August 1, 2013
Actual (reported)Primary Completion
July 1, 2018
Actual (reported)Study Completion
August 31, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2013
Actual (reported)August 12, 2013
Actual (reported)August 14, 2013
Actual (reported)July 1, 2018
Actual (reported)August 31, 2021
Actual (reported)March 2, 2022
Actual (reported)MELD Score
Change in MELD scoring system for assessing the severity of chronic liver disease; MELD (Model of End Stage Liver Disease) scoring system for assessing the severity of chronic liver disease; calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) MELD = 3.8\[Ln serum bilirubin (mg/dL)\] + 11.2\[Ln INR\] + 9.6\[Ln serum creatinine (mg/dL)\] + 6.4. MELD score range from 6-40 with higher scores indicating more severe liver disease and a worse outcome.
30 days
MELD Score
180 days
MELD Score
90 days
Placebo capsule that matches the probiotic capsule in appearance will be given once daily for 180 days.
Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.
Probiotic nutritional supplement; Lactobacillus Rhamnosus GG
Capsule manufactured without active ingredients.
University of Louisville
Louisville, Kentucky, 40202, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
U Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Vatsalya V, Feng W, Kong M, Hu H, Szabo G, McCullough A, Dasarathy S, Nagy LE, Radaeva S, Barton B, Mitchell M, McClain CJ. The Beneficial Effects of Lactobacillus GG Therapy on Liver and Drinking Assessments in Patients with Moderate Alcohol-Associated Hepatitis. Am J Gastroenterol. 2023 Aug 1;118(8):1457-1460. doi: 10.14309/ajg.0000000000002283. Epub 2023 Apr 11.
Vatsalya V, Cave MC, Kong M, Gobejishvili L, Falkner KC, Craycroft J, Mitchell M, Szabo G, McCullough A, Dasarathy S, Radaeva S, Barton B, McClain CJ. Keratin 18 Is a Diagnostic and Prognostic Factor for Acute Alcoholic Hepatitis. Clin Gastroenterol Hepatol. 2020 Aug;18(9):2046-2054. doi: 10.1016/j.cgh.2019.11.050. Epub 2019 Dec 4.
Mack C Mitchell, M.D.
U Texas Southwestern Medical Center
45 participants (actual enrollment reported by the registry).
First Submitted
August 12, 2013
First Posted
August 14, 2013
Study Start
August 1, 2013
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
July 1, 2018
Actual (reported)Study Completion
August 31, 2021
Actual (reported)Last Updated
March 2, 2022
Results First Posted
March 2, 2022
Record last verified: 2022-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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