SBIR Phase II: Non-Invasive Sampling and Analysis of the Human Gasstrointestinal (GI) Tract to Advance Inflammatory Bowel Disease Research

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This award is funded in whole or in part under the American Rescue Plan Act of 2021 (Public Law 117-2). The broader impact of this Small Business Innovation Research (SBIR) Phase II project will be to understand, and eventually manipulate, the immune, metabolic and microbial activities that occur in the intestines for the purpose of improving human health. Many important diseases are caused or regulated by activities in our intestines, yet very little is known about this hard-to-access organ. This project will develop a pill-sized gastrointestinal sampling device for routine, non-invasive sampling of the human gut and the analysis of its metabolic, microbial, and immunological content for the first time. The discoveries enabled by this project may lead to new commercial opportunities in diagnosing and treating important disorders, such as inflammatory bowel disease.The proposed project seeks to perform validations of a pill-sized gastrointestinal sampling device for routine, non-invasive sampling of the human gut using bench testing and evaluations of clinical samples. The team will also prepare the collected data for submission to the Food and Drug Administration for market clearance. Sampling the human intestinal tract safely, non-invasively and reliably is a daunting challenge due to the constraints on the size of a device that is safe to swallow and the variability of human physiology. The technology will lead to the commercialization of the first gut sampling device in the market. The device may help elucidate the roles of the gut microbes and their interactions with the immune system and metabolic processes in human health and disease.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.