Table 1.
Major Ongoing Studies of Novel Drug and Management Options for Alcoholic Liver Disease (ALD)
| Type of Intervention/Treatment | Mode of Action | Disease and Inclusion | Study Design | Identifier |
|---|---|---|---|---|
| Dietary supplement | ||||
| Lactobacillus Rhamnosus GG | Probiotic | Acute ASH, MELD score < 20 | Placebo controlled RCT | NCT01922895 |
| Profermin Plus® (fermented oats, barley malt, lecithin, and Lactobacillus plantarum 299v) | Probiotic and antioxidant | Chronic ALD | RCT vs. Fresubin® (protein energy drink) | NCT03863730 |
| Omega 5 fatty acid | Antioxidant | Severe ASH | Placebo controlled RCT | NCT03732586 |
| Saturated fats | Antioxidant | ASH, Maddrey DF score > 32 | RCT vs. soybean oil | NCT04084522 |
| S-Adenosyl methionine and choline | Antioxidant | ALD | Placebo controlled RCT | NCT03938662 |
| Pharmacological agent | ||||
| G-CSF | Growth factor | ASH, Maddrey DF score ≥ 32 | RCT vs. prednisolone | NCT02442180; NCT04066179 |
| G-CSF | Growth factor | ASH, Maddrey DF score ≥ 32 | RCT | NCT03703674 |
| Pegfilgrastim | Growth factor (G-CSF analog) | ASH, Maddrey DF score ≥ 32 | RCT | NCT02776059 |
| Methylprednisolone | Corticosteroids | ASH, Maddrey DF score ≥ 32 | Placebo controlled RCT | NCT03160651 |
| N-acetylcysteine | Antioxidant | ASH, Maddrey DF score > 32 | RCT vs. prednisolone | NCT03069300 |
| Vitamin C | Antioxidant to reduce infection | ASH with sepsis | RCT | NCT03829683 |
| Bovine colostrum | Protein, growth factor, and Ig to LPS | ASH, MELD score ≥ 21, Maddrey DF score > 32 | Placebo controlled RCT | NCT02473341 |
| DS-102 (Epeleuton) | Synthetic N-3 fatty acid, improve lipid metabolism | Acute severe ASH | Placebo controlled RCT | NCT03452540 |
| Nalmefene | Opioid antagonist, controls alcoholism | AC, Child A or B | Placebo controlled RCT | NCT02824354 |
| Canakinumab | Monoclonal antibody of IL-1 | ASH, Maddrey DF score ≥ 32 and MELD score ≤ 27 | Placebo controlled RCT | NCT03775109 |
| Livitol-70 | Herbal extracts, antioxidant and hepatoprotection | ALD, Maddrey DF score < 30 | Open label | NCT03503708 |
| Biological therapy | ||||
| Cellgram™ (Bone marrow-derived MSCs) | Progenitor, improving liver regeneration | AC, Child B | Open label | NCT03838250 |
| Transplantation | ||||
| Fecal microbiota transplantation | Rectifying gut microbiota | Severe ASH | RCT vs. prednisolone | NCT03091010 |
| Fecal microbiota transplantation | Rectifying gut microbiota | ASH, Maddrey DF score > 32 | Open label | NCT03827772 |
| Device/behavior | ||||
| AlcoChange | Behavioral remodeling by Smartphone apps and breathalyzer | ALD, motivation to maintain abstinence | Open label | NCT03474328 |
| SMS/exercise | SMS-message-based lifestyle intervention | AC, run-in physical exercise programs | RCT | NCT02811887 |
| WrisTAS biosensor | Alcohol biosensor monitoring | ALD, SOCRATES score > 26 | RCT | NCT03533660 |
| A-CHESS | Smartphone apps delivering comprehensive health enhancement support | ALD | Open label | NCT03388320 |
Information was collected from the website of Clinical Trials (https://clinicaltrials.gov/) by J. Xiao and F. Wang on April 10, 2020, with key words “alcoholic,” “alcohol,” or “alcoholism” in the searching area of “Condition or disease.” This table includes most ongoing clinical trials on ALD registered in the website, except trials (1) that have current status of “withdrawn” or “unknown status,” and (2) in which ALD is not the major disease or condition studied in the trial. AC, alcoholic cirrhosis; ALD, alcoholic liver disease; ASH, alcoholic steatohepatitis; DF, discriminant function; G-CSF, granulocyte colony-stimulating factor; Ig, immunoglobin; IL, interleukin; MELD, model for end-stage liver disease; MSC, mesenchymal stem cells; LPS, lipopolysaccharide; RCT, randomized controlled trials; SMS, short-message service; SOCRATES, stages of change readiness and treatment eagerness scale.