A Pilot Trial of Preoperative Oral Microbiota-based Investigational New Drug

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Microbiota and host form a complex super-organism with symbiotic relationships, which confer several benefits to the host. However, disruptions and alterations of the microbiome through environmental changes may disturb this symbiotic relationship and promote disease, particularly cancer(1). Growing...

Microbiota and host form a complex super-organism with symbiotic relationships, which confer several benefits to the host. However, disruptions and alterations of the microbiome through environmental changes may disturb this symbiotic relationship and promote disease, particularly cancer(1). Growing literature indicates the key role of gut microbiome and carcinogenesis. Perturbations of gut microbiome through changes in diet and use of antibiotics have been shown to sufficiently promote cancer in mouse models(2,3). The mechanisms, which microbiotas promote carcinogenesis, were through the increase in pro-inflammatory stimuli via Toll-like receptors (TLRs), which is a cornerstone of innate immunity, as well as the release of genotoxins, virulence factors, and carcinogenic metabolites. Furthermore, multiple studies also demonstrated that gut microbiota can alter the efficacy of anticancer therapy via immunological modulation in several preclinical models. These immunomodulatory effects include induction of TH1 response(4), increase in intratumoral cytotoxic T lymphocytes/regulatory T (Treg) cells ratio(5), increase in long-term memory CD4+ T helper cells, increase tumor-infiltrating interferon ? (IFN?) producing ??T cells. Nevertheless, the effects of changing gut microbiome using probiotics in human breast cancers are largely unknown. In this particular study, we propose to evaluate the immunological effects of a novel oral Microbiome Restoration Therapy™ (MRT), RBX7455, in patients with stage I-III breast cancer prior to undergoing definitive surgery.

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