Description of Collaborative Activity: |
To explore the potential role that fecal microbiota transplants (FMT) and pre/probiotics may play in cancer therapeutics and to address reproducibility and safety to inform translational human studies and clinical trials, National Cancer Institute (NCI) convened a “Strategic Workshop on Rigor and Reproducibility: Precision Fecal Microbiota Transplant and Microbiome Cancer Therapeutics” on September 5, 2019. This timely meeting brought together scientists and Food and Drug Administration (FDA) regulatory staff in the fields of FMT, pre/probiotics, nutrition, microbiome, synthetic biology, biomarkers, computation, immunology, gastroenterology, oncology, and infection.
Workshop Goals
Assess the current state of clinical research and clinical trials involving FMT and microbiome-based cancer therapeutics; Discuss the knowledge gaps and future opportunities in the field; Provide feedback to NCI and National Institutes of Health (NIH) regarding future priority areas to enhance precision- and mechanism-based rigor and reproducibility of defined microbiome-based therapeutic clinical research for cancer and other diseases
Workshop Focus Areas
Standardization (material manufacture and quality control), FMT donor selection, microbiome measurement, clinical protocols, procedures, and trial design; Microbiome composition and function as biomarkers associated with cancer therapy, such as reproducibility, safety, and efficacy; Confounding variables — host genetic and disease state, environment, antibiotics, diet and other lifestyle factors; Clinical efficacy and safety of FMT and microbiome-based cancer therapy; Clinically relevant models and human translational studies; Data sharing; FDA regulatory issues |
