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

SBIR 第二阶段：人类胃肠道的非侵入性采样和分析，以推进炎症性肠病研究

• 批准号: 2126329
• 负责人: Tidhar Shalon
• 金额: $ 97.28万
• 依托单位: ENVIVO BIO INC
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2126329&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Non; Invasive

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.

该奖项全部或部分根据2021年美国救援计划法案（公法117-2）资助。这个小企业创新研究（SBIR）第二阶段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。许多重要的疾病是由我们肠道的活动引起或调节的，但对这个难以进入的器官知之甚少。该项目将开发一种药丸大小的胃肠道采样装置，用于对人体肠道进行常规、非侵入性采样，并首次分析其代谢、微生物和免疫学含量。该项目的发现可能会为诊断和治疗炎症性肠病等重要疾病带来新的商业机会。拟议项目旨在通过实验室测试和临床样本评估，对药丸大小的胃肠道采样装置进行验证，用于常规、非侵入性的人体肠道采样。 该团队还将准备收集的数据，以提交给食品和药物管理局进行市场许可。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，这是由于对安全吞咽的装置尺寸的限制以及人体生理学的可变性。该技术将导致市场上第一个肠道采样设备的商业化。该设备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NSF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。