Table 2.
Gut microbiota-based clinical trials
|
Study
|
Mechanism
|
Trial phase
|
Patients (n)
|
ClinicalTrials.gov identifier
|
Estimated study completion date
|
| Nivolumab (Anti-PD1), Tadalafil and Oral Vancomycin in People with Refractory Primary Hepatocellular Carcinoma or Liver Dominant Metastatic Cancer from Colorectal or Pancreatic Cancers | Immunotherapy + Antibiotic | Phase II | 27 | NCT03785210 | 2022 |
| Administration of Rifaximin to Improve Liver Regeneration and Outcome Following Major Liver Resection (ARROW) | Antibiotic | Phase II | 96 | NCT02555293 | 2020 |
| Efficacy of the Combination of Simvastatin Plus Rifaximin in Patients with Decompensated Cirrhosis to Prevent ACLF Development (2018-001698-25) | Antibiotic | Phase III | 240 | NCT03780673 | 2021 |
| Comparative Study of Rifaximin Versus Norfloxacin in the Secondary Prophylaxis of Spontaneous Bacterial Peritonitis (SBP) | Antibiotic | Phase III | 100 | NCT02120196 | 2023 |
| Efficacy of Antibiotic Therapy in Severe Alcoholic Hepatitis Treated with Prednisolone (AntibioCor) | Antibiotic | Phase III | 280 | NCT02281929 | 2019 |
| Rifaximin Reduces the Complications of Decompensated Cirrhosis: A Randomized Controlled Trial | Antibiotic | Phase IV | 200 | NCT02190357 | 2019 |
| Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy and Hepatically Impaired Subjects | Antibiotic | Phase IV | 18 | NCT03818672 | 2019 |
| Efficacy, Safety, And Pharmacokinetics of Rifaximin In Subjects with Severe Hepatic Impairment and Hepatic Encephalopathy | Antibiotic | Phase IV | 100 | NCT01846663 | 2021 |
| Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE) (OHE) | Antibiotic | Phase II | 325 | NCT03515044 | 2019 |
| Mastiha Treatment for Obese with NAFLD Diagnosis (MAST4HEALTH) | Prebiotic | Early Phase I | 52 | NCT03135873 | 2019 |
| Study on the Optimal Strategy for Acute-on-chronic Liver Failure with Integrative Treatment | Prebiotic | N/A | 510 | NCT03577938 | 2020 |
| Efficacy of Albumin Therapy with Standard Medical Treatment (SMT) as Compared to Standard Medical Treatment (SMT) in Improving Patient Survival and Immune Modulation in Patients with Acute on Chronic Liver Failure (ASIA Trial). | Prebiotic | N/A | 200 | NCT03754400 | 2020 |
| Impact of a Specific Micronutrient-probiotic-supplement on Fatty Liver of Patients After Mini-Gastric Bypass Surgery (FMG-01) | Probiotic | Phase III | 60 | NCT03585413 | 2019 |
| Probiotics in the Treatment of NAFLD | Probiotic | N/A | 58 | NCT02764047 | 2018 |
| Probiotics in NASH Patients - PROBILIVER TRIAL (NASH) | Probiotic | N/A | 46 | NCT03467282 | 2021 |
| Profermin®: Prevention of Progression in Alcoholic Liver Disease by Modulating Dysbiotic Microbiota (SYN-ALD) | Probiotic | N/A | 40 | NCT03863730 | 2031 |
| Novel Therapies in Moderately Severe Acute Alcoholic Hepatitis (NTAH-Mod) | Probiotic | N/A | 130 | NCT01922895 | 2019 |
| Probiotics in the Prevention of Hepatocellular Carcinoma in Cirrhosis | Probiotic | N/A | 280 | NCT03853928 | 2023 |
| Dietary Modulation of Intestinal Microbiota as Trigger of Liver Health: Role of Bile Acids - "A Diet for Liver Health" (ADLH) | Synbiotic | N/A | 84 | NCT03897218 | 2020 |
| Investigation of Synbiotic Treatment in NAFLD (INSYTE) | Synbiotic | N/A | 100 | NCT01680640 | 2019 |
| Fecal Microbiota Transplantation (FMT) in Nonalcoholic Steatohepatitis (NASH). A Pilot Study | FMT | Phase I | 5 | NCT02469272 | 2018 |
| Fecal Microbiota Transplantation for the Treatment of Non-Alcoholic Steatohepatitis (FMT-NASH) | FMT | Phase I | 15 | NCT03803540 | 2021 |
| Fecal Microbial Transplant for Alcohol Misuse in Cirrhosis | FMT | Phase I | 20 | NCT03416751 | 2019 |
| FMT in Cirrhosis and Hepatic Encephalopathy | FMT | Phase II | 100 | NCT03796598 | 2023 |
| Fecal Microbiota Transplant as Treatment of Hepatic Encephalopathy | FMT | Phase II | 30 | NCT03420482 | 2021 |
| Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): A Pilot Study | FMT | Phase II | 10 | NCT02255617 | 2019 |
| Fecal Transplant for Hepatic Encephalopathy | FMT | Phase II | 30 | NCT03439982 | 2021 |
| Trial of Faecal Microbiota Transplantation in Cirrhosis (PROFIT) | FMT | Phase III | 32 | NCT02862249 | 2019 |
| To Assess the Role of Fecal Microbiota Transplant in Acute Liver Failure | FMT | N/A | 40 | NCT03363022 | 2018 |