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

该奖项全部或部分由《2021年美国救援计划法案》（公法117-2）资助。这项小企业创新研究（SBIR）二期项目的更广泛影响将是了解并最终操纵肠道中发生的免疫、代谢和微生物活动，以改善人类健康。许多重要的疾病都是由我们肠道的活动引起或调节的，但对这个难以接近的器官知之甚少。该项目将首次开发一种药丸大小的胃肠道采样设备，用于对人体肠道进行常规、非侵入性采样，并分析其代谢、微生物和免疫学内容。该项目的发现可能会在诊断和治疗重要疾病（如炎症性肠病）方面带来新的商业机会。拟议的项目旨在通过台架测试和临床样本评估，对一种药丸大小的胃肠道采样装置进行常规、非侵入性的人体肠道采样验证。该团队还将准备收集到的数据提交给食品和药物管理局，以获得市场许可。安全、无创和可靠地对人体肠道进行采样是一项艰巨的挑战，因为安全吞咽设备的大小和人体生理的可变性受到限制。这项技术将导致市场上第一个肠道采样设备的商业化。该装置可能有助于阐明肠道微生物的作用及其与免疫系统和代谢过程在人类健康和疾病中的相互作用。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.