Development and clinical evaluation of the CapScan gastrointestinal sampling device for metabolomics monitoring

用于代谢组学监测的 CapScan 胃肠道采样装置的开发和临床评价

• 批准号: 10596615
• 负责人: Tidhar Dari Shalon
• 金额: $ 59.74万
• 依托单位: ENVIVO BIO INC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10596615
• 关键词: Aftercare; Amendment; Antibiotic Therapy; Ascending colon; Blood Tests; Cecum; Clinical; Clinical Research; Collaborations; Collection; DNA sequencing; Deglutition; Development; Devices; Dimensions; Disease; Duodenum; Elements; Feces; Food; Gastric Emptying; Gastroenterologist; Gastrointestinal Diseases; Gastrointestinal tract structure; Generations; Goals; Growth; Health; Hour; Human; Human Volunteers; Intestines; Length; Liquid substance; Measures; Medicine; Metabolic; Metabolic Pathway; Metagenomics; Microbe; Modeling; Molecular Weight; Monitor; Patients; Persons; Polyvinyl Alcohol; Protocols documentation; Proton Pump Inhibitors; Recovery; Reproducibility; Research Personnel; Rod; Sampling; Serious Adverse Event; Shapes; Small Intestines; Specific qualifier value; Specificity; Stomach; Technology; Testing; Time; Tube; Universities; capsule; design; experimental study; feasibility testing; gastrointestinal; gut bacteria; gut microbes; gut microbiota; healthy volunteer; human subject; ileum; jejunum; metabolome; metabolomics; microbial; microbial genomics; microbiome; milliliter; novel; prototype; regional difference; research clinical testing; rifaximin; safety assessment

Project Abstract The goal of this project is to develop the CapScan gastrointestinal (GI) tract sampling capsule, and to utilize this device to advance our understanding of gastrointestinal disorders. CapScan is a novel ingestible device with the potential to routinely collect and analyze the microbiota of the GI tract, including the metabolic transformation of food products by gut microbes. We will develop, bench test and assess the safety, reproducibility, regional specificity of the CapScan device on healthy human volunteers. We will then utilize the CapScan device in two additional studies to test the effect of a proton pump inhibitor (PPI) on the microbiome and metabolome and to measure the regional differences in the GI tract in patients with small intestinal bacterial overgrowth (SIBO) before and after antibiotic treatment. Given the centrality of the gut to human health, there will likely be additional uses of the CapScan technology in monitoring a person's health, eventually making CapScan as routine and informative in the practice of medicine as a blood test is today.

项目摘要 该项目的目标是开发 CapScan 胃肠道 (GI) 采样胶囊，并利用 该设备可以增进我们对胃肠道疾病的了解。 CapScan 是一种新颖的可摄入设备 具有定期收集和分析胃肠道微生物群的潜力，包括代谢 肠道微生物对食品的转化。我们将开发、台架测试和评估安全性， CapScan 设备对健康人类志愿者的再现性和区域特异性。然后我们将利用 CapScan 设备在另外两项研究中测试质子泵抑制剂 (PPI) 对微生物组的影响 和代谢组，并测量小肠患者胃肠道的区域差异 抗生素治疗前后细菌过度生长（SIBO）。鉴于肠道对人类的中心地位 CapScan 技术可能会在监测个人健康方面有更多用途， 最终使 CapScan 成为医学实践中的常规检测，并提供丰富的信息，就像今天的血液检测一样。