Table 2.

Clinical trials on gut microbiota and ICIs.

NCT number	Condition or disease	ICIs	Interventions	Title	No. of enrolled patients	Location	Phase
NCT03700437	Non-small Cell Lung Cancer	Pembrolizumab	Dietary intervention Fast-Mimicking Diet (FMD)	Fasting-Mimicking Diet with Chemo-immunotherapy in Non-small Cell Lung Cancer (NSCLC)	40	USA	Not Applicable
NCT03595540	Cancer	Opdivo, Keytruda	FMD for 5 days	Fasting-Mimicking Diet in Patients Undergoing Active Cancer Treatment	60	Italy	Not Applicable
	Breast Cancer
	Colorectal Cancer
NCT03686202	All solid tumors	PD-1/PD-L1 blockade	MET-4	Feasibility Study of Microbial Ecosystem Therapeutics (MET-4) to Evaluate Effects of Fecal Microbiome in Patients on ImmunOtherapy (MET4-IO)	65	Canada	Phase I
NCT04163289	RCC	Nivolumab, Ipilimumab	FMT	Preventing Toxicity in Renal Cancer Patients Treated With Immunotherapy Using Fecal Microbiota Transplantation (PERFORM)	20	Canada	Phase I
NCT04130763	Gastrointestinal system cancer	PD-1 blockade	FMT	Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of Anti- PD-1	5	China	Phase I
NCT03353402	Melanoma	PD-1 blockade	FMT	Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy	40	Israel	Phase I
NCT04056026	Metastatic mesothelioma	Pembrolizumab	FMT	A Single Dose FMT Infusion as an Adjunct to Keytruda for Metastatic Mesothelioma	1	USA	Phase I
NCT04208958	Metastatic cancer, melanoma, gastroesophageal junction adenocarcinoma, colorectal cancer	PD-1 blockade	VE800, nivolumab, vancomycin oral capsule	Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer (Consortium-IO)	111	USA	Phase I/II
NCT03341143	Melanoma	Pembrolizumab	FMT	Fecal Microbiota Transplant (FMT) in Melanoma Patients	20	USA	Phase II
NCT04116775	Prostate cancer	Pembrolizumab	FMT	Fecal Microbiota Transplant and Pembrolizumab for Men With Metastatic Castration Resistant Prostate Cancer	32	USA	Phase II
NCT04136470	NSCLC, melanoma	Nivolumab, Ipilimumab, Atezolizumab	—	BioForte Technology for in Silico Identification of Candidates for a New Microbiome-based Therapeutics and Diagnostics	130	Poland	Discovery
NCT04169867	Melanoma	Nivolumab, Ipilimumab, Atezolizumab	—	Polish Microbiome Map	1160	Poland	Discovery
NCT04291755	NSCLC, colorectal cancer	Pembrolizumab	Pembrolizumab injection	Development and Analysis of a Stool Bank for Cancer Patients	100	USA	Discovery
NCT03353402	Melanoma	PD-1 blockade	FMT	Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy	40	Israel	Phase I

MET4, Microbial Ecosystem Therapeutics.

VE800: an orally administered live biotherapeutic product consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions.