Table 3.

Clinical trials of probiotics, bacteria consortia, prebiotics. and dietary interventions manipulating the gut microbiome in immunotherapy

	Cancer type	Enrollment	Immunotherapy	Microbial intervention	Phase	Location	Status
Probiotics and bacteria consortia
NCT03595683	melanoma	8	pembrolizumab	Bifidobacterium longum EDP1503	2	USA	suspended
NCT03637803	NSCLC, RCC, melanoma, bladder cancer	63	pembrolizumab	MRx0518 (a lyophilized proprietary bacterium strain)	1/2	USA	terminated
NCT03686202	all solid tumors	65	anti-PD-1/PD-L1	MET-4	2/3	Canada	active, not recruiting
NCT03775850	CRC, triple-negative breast cancer, NSCLC, bladder, gastroesophageal, RCC	69	pembrolizumab	Bifidobacterium longum EDP1503	1	USA, Canada	completed
NCT03817125	melanoma	14	nivolumab	SER-401	1	USA	completed
NCT03829111	RCC	30	nivolumab+ipilimumab	CBM588	1	USA	active, not recruiting
NCT04208958	melanoma, gastric, gastroesophageal junction adenocarcinoma, CRC	111	nivolumab	VE800	1/2	USA	completed
NCT04601402	solid tumor, NSCLC, HNSCC, urothelial carcinoma	11	avelumab	live biotherapeutic product GEN-001	1	USA	completed
NCT04699721	NSCLC	40	nivolumab+paclitaxel+carboplatin	BiFico	1	China	active, not recruiting
NCT04909034	NSCLC	30	pembrolizumab	fermented soybean extract MicrSoy-20 (MS-20)	2	Taiwan	recruiting
NCT05032014	liver	46	anti-PD-1	Probio-M9	N/A	China	recruiting
NCT05094167	NSCLC	46	carrilizumab+platinum	Kex02 (Lactobacillus Bifidobacterium V9)	N/A	China	recruiting
NCT05122546	RCC	31	nivolumab+cabozantinib S-malate	CBM588	1	USA	active, not recruiting
NCT05220124	bladder, urothelial	190	immunotherapy	live combined Bifidobacterium, Lactobacillus and Enterococcus capsules	4	China	recruiting
NCT05354102	NSCLC, melanoma, RCC	12	nivolumab	BMC128	1	Israel	recruiting
NCT05620004	advanced HCC	30	carrilizumab+apatinib mesylate	Bifidobacterium bifidum	1/2	China	recruiting
Prebiotics
NCT01829373	lung	5	lung cancer vaccine	yeast-derived β-glucan	1	USA	completed
NCT04552418	solid tumor	12	ipilimumab+nivolumab	potato starch (Bob’s Red Mill)	1	USA	completed
NCT06049576	RCC	30	nivolumab+ipilimumab	camu camu	1	USA	recruiting
Dietary intervention
NCT03340935	Cancer	101	standard-of-care treatment	FMD: a 5-day plant-based, low-calorie, low-protein, low-carbohydrate diet	N/A	Italy	completed
NCT03595540	breast, CRC	90	nivolumab (Opdivo), pembrolizumab (Keytruda)	FMD Prolon	N/A	Italy	completed
NCT03700437	NSCLC	12	pembrolizumab	FMD Chemolieve	N/A	USA	completed
NCT03709147	advanced LKB1-inactive Lung adenocarcinoma	64	pembrolizumab	metformin hydrochloride/metformin hydrochloride + FMD	2	Italy	unknown
NCT04316520	metastatic RCC	20	nivolumab+ipilimumab, pembrolizumab+axitinib, sunitinib or pazopanib	ketogenic diet 2:1	N/A	France	recruiting
NCT04645680	melanoma	42	pembrolizumab/nivolumab	isocaloric high-fiber diet	2	USA	recruiting
NCT04866810	melanoma	80	relatlimab+nivolumab	high-fiber, plant-based diet + exercise	N/A	USA	recruiting
NCT05119010	metastatic RCC	60	nivolumab+ipilimumab	ketogenic diet, BHB (β-hydroxybutyrate)	N/A	France	recruiting
NCT05083416	HNSCC	29	nivolumab, pembrolizumab, atezolizumab, avelumab, or durvalumab	prolonged nightly fasting	N/A	USA	active, not recruiting
NCT05356182	integrative oncology	30	anti-PD-1/PD-L1/CTLA-4	low-protein diet (10%)	N/A	USA	recruiting
NCT05384873	metastatic NSCLC	180	immunotherapy	immunonutrients (Oral Impact): high-calorie, high-protein nutritional liquid supplement	N/A	No data	not recruiting
NCT05703997	SCLC	20	atezolizumab	cyclic, 5-day, calorie-restricted, plant-based, low-protein, low-carbohydrate diet	2	Italy	not recruiting
NCT05763992	triple-negative breast cancer	145	pembrolizumab	fasting-like approach (FLA): a plant-based, low-calorie, low-protein, low-carbohydrate diet	2	Italy	recruiting

HNSCC, head and neck squamous cell carcinoma; SCLC, small cell lung cancer.