Table 2. Current clinical trials using FMT in HBV or HCC from Clinicaltrial.gov.
| Status | Study title | Conditions | Interventions | Study design | Outcome measures | Number enrolled | NCT number |
|---|---|---|---|---|---|---|---|
| Complete | The effect of gut microbiota on postoperative liver function recovery in patients with hepatocellular carcinoma. | Gut microbiota; hepatocellular carcinoma | / | a. Observational model: b. Cohort; Time c. Perspective: prospective | Diversity analysisSpecies composition analysis Species differential analysis |
200 | NCT04303286 |
| Recruiting | Efficacy of addition of fecal microbiota transplant (FMT) and plasma exchange to tenofovir in comparison to monotherapy with tenofovir in ACLF-HBV. | Acute-on-chronic; liver failure hepatitis B | 1. Biological: plasma exchange 2. Drug: tenofovir 3. Other: fecal microbiota transplantation. |
a. Allocation: randomized b. Intervention model: parallel assignment c. Masking: none (open label) d. Primary purpose: treatment |
1. Overall survival in both groups 2. Reduction in HBV DNA level. 3. Reduction in CTP Score in both groups (and 8 more...). |
70 | NCT04431375 |
| Completed | Randomized controlled trial comparing the efficacy and safety of FMT in hepatitis B reactivation leads to acute on chronic liver failure. | Acute on chronic liver failure | 1. Drug: tenofovir 2. Drug: fecal microbiota transplantation (FMT). |
a. Allocation: randomized b. Intervention model: parallel assignment c. Masking: none (open label) d. Primary purpose: treatment |
1. Transplant free survival. 2. Reduction in hepatitis B virus DNA level ≥ 2 log. 3. Improvement in MELD (Model for End Stage Liver Disease) score. (and 10 more...) |
64 | NCT02689245 |
Abbreviations: HBV, hepatitis B virus; HCC, hepatocellular carcinoma.