Table 4.
Clinical trials of manipulating the gut microbiota to enhance immunotherapy
| Type | Conditions | Interventions | Phases | Enrollment | Funder type | Start date | Completion date | Locations | Study status | NCT number |
|---|---|---|---|---|---|---|---|---|---|---|
| Probiotics | RCC | CBM 588 + ipilimumab + nivolumab | Phase1 | 30 | Other | 2019/5/14 | 2023/6/11 | US | Active not recruiting | NCT03829111 |
| Probiotics | Advanced HCC | Bifidobacterium bifidum + carrilizumab + apatinib mesylate | Phase1|phase2 | 30 | Other | 2021/11/1 | 2024/10/31 | China | Recruiting | NCT05620004 |
| Probiotics | NSCLC | Lactobacillus bifidobacterium V9(Kex02) + carilizumab + platinum | – | 46 | Other | 2021/10/19 | 2023/12/30 | China | Recruiting | NCT05094167 |
| Probiotics | Melanoma | Pembrolizumab + EDP1503 | Phase2 | 8 | Other | 2018/10/2 | 2023/11/2 | US | Suspended | NCT03595683 |
| Probiotics | Liver cancer | M9 + PD-1 inhibitors | – | 46 | Other | 2021/11/19 | 2023/12/30 | China | Recruiting | NCT05032014 |
| Probiotics | Metastatic melanoma | SER-401 + nivolumab | Phase1 | 14 | Other | 2019/1/28 | 2022/3/4 | US | Completed | NCT03817125 |
| Probiotics | All solid tumors | MET-4 + ICI | Phase2|phase3 | 65 | Other | 2018/11/30 | 2025/12/1 | Canada | Active not recruiting | NCT03686202 |
| Probiotics | NSCLC, melanoma, RCC | BMC128 + nivolumab | Phase1 | 12 | Industry | 2022/5/1 | 2023/5/1 | Israel | Recruiting | NCT05354102 |
| Probiotics | RCC | Clostridium butyricum CBM 588 + nivolumab and cabozantinib | Phase1 | 30 | Other | 2021/11/1 | 2023/11/30 | US | Recruiting | NCT05122546 |
| FMT | GI system cancer | FMT + PD-1 inhibitors | Phase1 | 10 | Other | 2020/1/3 | 2021/12/1 | China | Unknown | NCT04130763 |
| FMT | RCC | FMT + ICI | Phase1|phase2 | 50 | Other | 2021/2/18 | 2024/2/19 | Italy | Recruiting | NCT04758507 |
| FMT | Mesothelioma | FMT + keytruda | Early_phase1 | 1 | Other | 2018/9/18 | 2018/12/18 | US | Completed | NCT04056026 |
| FMT | Advanced HCC | FMT + atezolizumab + bevacizumab | Phase2 | 48 | Other | 2024/1/1 | 2027/3/1 | Germany | Not yet recruiting | NCT05690048 |
| FMT | Cancer | FMT + ICI | – | 30 | Other | 2022/3/14 | 2025/3/31 | Switzerland | Recruiting | NCT05273255 |
| FMT | HCC | FMT + atezolizumab + bevacizumab | Phase2 | 12 | Other | 2023/3/1 | 2026/1/1 | Austria | Not yet recruiting | NCT05750030 |
| FMT | RCC | FMT + nivolumab + ipilimumab | Phase1 | 20 | Other | 2020/1/23 | 2028/11/1 | Canada | Recruiting | NCT04163289 |
| FMT | Melanoma | FMT + ICI | Phase1|phase2 | 24 | Other | 2022/7/1 | 2025/4/1 | Netherlands | Recruiting | NCT05251389 |
| FMT | NSCLC | FMT + PD-1/PDL-1 inhibitors | Phase1 | 20 | Other | 2021/9/1 | 2022/12/30 | China | Not yet recruiting | NCT05008861 |
| FMT | Melanoma | FMT + ICI | Phase1 | 40 | Other_gov | 2017/11/30 | 2021/12/30 | Israel | Unknown | NCT03353402 |
| FMT | Metastatic lung cancer | FMT + ICI | Phase2 | 80 | Other | 2022/9/1 | 2028/6/30 | Israel | Not yet recruiting | NCT05502913 |
| FMT | Lung cancer | FMT + PD1 inhibitors | – | 20 | Other | 2021/4/23 | 2022/12/31 | Spain | Recruiting | NCT04924374 |
| FMT | Melanoma | FMT + pembrolizumab/nivolumab | Phase1 | 20 | Other | 2019/3/27 | 2023/12/1 | Canada | Active not recruiting | NCT03772899 |
| FMT | Solid carcinoma | FMT + immunotherapy | – | 60 | Other | 2018/6/4 | 2023/4/30 | Korea | Unknown | NCT04264975 |
| Antibiotics | Pancreatic cancer | Antibiotics + pembrolizumab | Phase4 | 0 | Other | 2019/6/25 | 2020/6/1 | US | Withdrawn | NCT03891979 |
| Antibiotics | Pancreatic cancer | Chemotherapy + antibiotics + pembrolizumab | Phase2 | 25 | Other | 2022/8/1 | 2029/4/1 | US | Not yet recruiting | NCT05462496 |
| Diet | Head and neck cancer | Prolonged nightly fasting + ICI (nivolumab/pembrolizumab/atezolizumab/avelumab/durvalumab) | – | 29 | Other | 2021/10/20 | 2023/5/24 | US | Active not recruiting | NCT05083416 |
| Diet | Solid tumor | Potato starch + ICIs | Early_phase1 | 12 | Other | 2021/6/2 | 2023/1/24 | US | Completed | NCT04552418 |
| Diet | Lung cancer | Fish oil + immunotherapy/chemotherapy/TKI | – | 50 | Other | 2022/11/15 | 2024/5/15 | Brazil | Recruiting | NCT04965129 |
| Diet | Melanoma | Dietary intervention + pembrolizumab/nivolumab | Phase2 | 42 | Other | 2020/6/24 | 2024/2/1 | US | Recruiting | NCT04645680 |
| Diet and exercise | Melanoma | Immunotherapy | – | 80 | NIH | 2023/5/15 | 2025/10/31 | US | Recruiting | NCT04866810 |
US United States, GI gastrointestinal, NSCLC non-small cell lung cancer, RCC renal cell carcinoma, HCC hepatocellular carcinoma, ICI immune checkpoint inhibitor, FMT fecal microbiota transplantation, TKI tyrosine kinase inhibitor