Table 2.

Interventional clinical trials that target the microbiome in pancreatic ductal adenocarcinoma and other GI cancers (source: ClinicalTrials.gov)

Study title	Study design	Intervention	Conditions	NCT identifier	Status
Gut Microbiome Modulation to Enable Efficacy of Checkpoint-based Immunotherapy in Pancreatic Adenocarcinoma	Interventional	Drug: Pembrolizumab Drug: Ciprofloxacin Drug: Metronidazole	Pancreatic Cancer	NCT03891979	Withdrawn
A Study of Live Biotherapeutic Product MRx0518 With Hypofractionated Radiation Therapy in Resectable Pancreatic Cancer	Interventional phase I	Drug: MRx0518 Radiation: hypofractionated preoperative radiation	Pancreatic Cancer	NCT04193904	Recruiting
MS-20 on Gut Microbiota and Risk/Severity of Cachexia in Pancreatic Cancer Patients	Interventional	Drug: MS-20 Other: Placebo	Pancreatic Cancer	NCT04600154	Recruiting
Phase II Study of Nivolumab (Anti-PD1), Tadalafil and Oral Vancomycin in Patients With Refractory Primary Hepatocellular Carcinoma or Liver Dominant Metastatic Cancer From Colorectal or Pancreatic Cancers	Interventional phase II	Drug: Nivolumab Drug: Tadalafil Drug: oral vancomycin	Hepatocellular carcinoma Metastatic pancreatic cancer Metastatic colorectal cancer	NCT03785210	Recruiting
Pilot Trial of Fecal Microbiota Transplantation and Re- Introduction of Anti-PD-1 Therapy in dMMR Colorectal Adenocarcinoma Anti-PD 1 Non-Responders	Interventional phase I	Drug: fecal microbiota transplantation capsule Drug: Nivolumab Drug: Pembrolizumab	Colorectal cancer	NCT04729322	Recruiting
Investigator-initiated Trial of Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of Anti-PD-1 in Patients With PD-1 Resistant Digestive System Cancers	Interventional phase I	Drug: fecal microbiota transplantation capsule Drug: anti-PD-1 therapy	Gastrointestinal cancers	NCT04130763	Recruiting
A Phase I/II Open-label Study of EDP1503 Alone and in Combination With Pembrolizumab in Patients With Advanced Metastatic Colorectal Carcinoma, Triple- negative Breast Cancer, and Checkpoint Inhibitor Relapsed Tumors	Interventional phase I/II	Drug: EDP1503 Drug: Pembrolizumab	Colorectal cancer Gastroesophageal cancer Triple negative breast cancer Non-small cell lung cancer Renal cell carcinoma	NCT03775850	Recruiting
Fusobacterium Nucleatum Eradication in Postoperative Stage II/III Colorectal Cancer (FINER-PACE) by Oral Metronidazole: A Multi-left, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.	Interventional phase II/III	Drug: Metronidazole Drug: Placebo	Colorectal cancer	NCT04264676	Recruiting