Table 3 Ongoing select clinical studies investigating the effect of gut microbiota on anticancer therapies

Observational, n = 49

TNBC, newly diagnosed

Neoadjuvant chemotherapy with collection with pre- and post-therapy stool and PB samples

pCR rate as associated with composition of intestinal microbiota and subsequent short-term alterations in composition

NCT03586297

Observational, n = 80

Metastatic CRC, first-line; metastatic carcinoma, first-line anti-PD-1/PD-L1 therapy

FOLFOX or FOLFIRI or anti-PD-1/PD-L1 therapy with collection of pre-therapy and interval stool samples

Tumor response correlated with presence and amounts of species

NCT02960282

Observational, n = 120

AML, newly diagnosed or undergoing HSCT

Serial stool samples analyzed by next-generation sequencing

Association between changes in the intestinal microbiota and the incidence of gastrointestinal GVHD

NCT03148197

Case–control, n = 200

Glioblastoma multiforme, first-line

Concurrent chemoradiation (temozolomide) or radiation therapy or healthy control and collection of pre- and post-surgery stool samples

Pre-operative gut microbiome composition, perturbation of gut microbiota by temozolomide, and correlation of gut microbiota and prognosis

NCT03631823

Phase I, n = 40

Advanced melanoma, treatment refractory

FMT from responders of immunotherapy

Safety and comparison of gut microbiome composition pre- and post-FMT

NCT03353402

Phase I/II, n = 20

AML or high-risk MDS, first-line

Induction therapy + autologous FMT

Efficacy in dysbiosis correction by measure of microbiota diversity and eradication of MDRB

NCT02928523

Phase II, n = 20

Advanced melanoma, treatment refractory

FMT + pembrolizumab

ORR

NCT03341143

Phase II, n = 144

Any hematologic malignancy undergoing HSCT

Piperacillin–tazobactam or cefepime

Fold-change in Clostridiales abundance

NCT03078010