Table 1.

Clinical research on intestinal microbiota and tumor immunotherapy.

Study type	NCT number	Condition or disease	Immunotherapeutic drugs	Microbiological interventions	Purpose	Estimated enrollment	Primary outcome	Study design	Location
Interventional	NCT04163289	Renal cell carcinoma	Ipilimumab/nivolumab	FMT	To evaluate the efficacy and safety of FMT in the prevention of adverse reactions in immunotherapy	20	Occurrence of immune-related colitis associated with ipilimumab/nivolumab treatment	Single group Open label	Canada
	NCT04130763	Gastrointestinal system cancer	PD-1 inhibitor	FMT	To determine whether the FMT capsule improves the response rate of anti-PD-1 treatment	10	Objective response rate Rate of abnormal vital signs and laboratory test results The number of adverse events	Single group Open label	China
	NCT03353402	Melanoma stage IV Unresectable stage III melanoma	Unspecified	FMT	Altering the gut microbiota of melanoma patients who failed immunotherapy using FMT from responding patients	40	Incidence of FMT-related adverse events Proper implant engraftment	Single group Open label	Israel
	NCT04264975	Solid carcinoma	Unspecified	FMT	Part 1: development of microbiome biomarkers for immuno-oncology; part 2: proof-of-concept trial on the fecal microbiota transplantation in patients who are being treated with immunotherapy for advanced solid tumor	60	Overall response rate	Single group Open label	Korea
	NCT03341143	Melanoma	Pembrolizumab	FMT	To determine if the FMT improves the body's ability to fight your cancer	20	Objective response rate	Single group Open label	United States
	NCT03829111	Advanced renal cell carcinoma Clear cell renal cell carcinoma Metastatic renal cell carcinoma Stage III renal cell cancer AJCC v8 Stage IV renal cell cancer AJCC v8 Unresectable renal cell carcinoma	Nivolumab Ipilimumab	Clostridium butyricum CBM 588 probiotic strain	To determine the effect of clostridium butyricum CBM 588 probiotic strain (CBM 588) (in combination with nivolumab/ipilimumab) on the gut microbiome in patients with metastatic renal cell carcinoma (mRCC)	30	Change in Bifidobacterium composition of stool	Randomized Parallel assignment Open label	United States
	NCT03686202	All solid tumors	PD-1/PD-L1 inhibitor	MET-4	To assess the safety, tolerability and engraftment of MET-4 strains when given in combination with immune checkpoint inhibitors	65	Cumulative relative abundance of immunotherapy-responsiveness associated species Changes in relative abundance of immunotherapy-responsiveness associated MET-4 strains Number of participants with treatment-related adverse events	Randomized Single group Open label	Canada
Observational	NCT04136470	Non-small-cell lung cancer Microbiome Metagenome Immunotherapy Melanoma	Nivolumab Ipilimumab Atezolizumab	/	To develop and validate the BioForte technology. Its main functionality should be to in silico determine candidates for novel microbiome-based therapeutics and diagnostics.	130	Microbial diversity in stool samples Number of responders and nonresponders on immunotherapy	Case-only Cross-sectional	Poland
	NCT03797170	Diffuse large B cell lymphoma	Front-line R-CHOP (rituximab-cyclophosphamide, doxorubicin, vincristine, prednisone)	/	To study the functional gut microbiota layout in association with specific patterns of treatment response in de novo DLBCL undergoing standard first line chemoimmunotherapy	50	Gut microbiota dysbiosis assessment (bacterial DNA of gut microbiota in all patients)	Cohort Prospective	Italy
	NCT03557749	Immune and microbial reconstitution Systemic viral infection Acute-graft-versus-host disease Chronic graft-versus-host-disease Recurrent malignancy Cytokine release syndrome Allogenic related donors Cell therapy/immunotherapy patients	Hematopoietic cell transplant Cell therapy Novel immunotherapy	/	To monitor the immune and microbial reconstitution in hematopoietic cell transplantation and novel immunotherapies	1600	Immune function after hematopoietic cell transplant Immune function after cell therapy/immunotherapy Correlate immune parameters Correlate microbiota changes and their interactions with the host with outcomes of hematopoietic cell transplant	Cohort Prospective	United States
	NCT04169867	Melanoma Healthy volunteers Microbiome Metagenome Immunotherapy	Nivolumab Ipilimumab Atezolizumab	/	To observe the gut microbiota and diet of melanoma patients receiving immunotherapy	1160	Microbial diversity in stool samples Eating habits and health survey	Case-only Cross-sectional	Poland

FMT: fecal microbiota transplantation; /: none.