SBIR Phase I: Faecalibacterium prausnitzii supernatant oral formulations to improve insulin sensitivity and treat prediabetes

这项小企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力是预防和治疗前驱糖尿病和2型糖尿病。超过三分之一的美国成年人患有前驱糖尿病或2型糖尿病，相关医疗费用超过3270亿美元。目前的治疗方法经常出现不良反应或对某些患者无效。预计到2024年，仅五大人类糖尿病药物每年就将耗资230亿美元。本项目提出了一种由有益肠道细菌组成的后生物混合物的新型糖尿病治疗方法。这将改善糖尿病前期患者的临床结果。这项小型企业创新研究（SBIR）一期项目将评估有效性并阐明一种潜在的基于微生物组的口服治疗的机制，这种治疗可以有效降低糖尿病相关标志物。三个技术目标是：1)评估技术并证明与现有降糖药相比具有同等或更好的性能；2)更好地了解导致治疗前驱糖尿病和2型糖尿病疗效的机制；3)从后生物混合物中识别活性分子。这些目标将通过啮齿动物试验、细胞分析和先进的分离技术来实现。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。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to prevent and treat prediabetes and type 2 diabetes. More than 1 in 3 American adults have prediabetes or type 2 diabetes with associated healthcare costs exceeding $327 billion. Current therapies often present adverse effects or are ineffective in some patients. The top five human diabetes drugs alone are expected to cost $23 billion annually by 2024. This project advances a novel diabetic treatment composed of a postbiotic mixture from beneficial gut bacteria. This will improve clinical outcomes for prediabetic patients.This Small Business Innovation Research (SBIR) Phase I project will evaluate the efficacy and elucidate the mechanism of a potential microbiome-based treatment toward an oral treatment that effectively reduces diabetes-associated markers. The three technical objectives are to: 1) evaluate the technology and demonstrate equivalent or superior performance compared to existing antidiabetic drugs, 2) better understand the mechanism that leads to efficacy in the treatment of prediabetes and type 2 diabetes, and 3) identify the active molecule(s) from the postbiotic mixture. These objectives will be carried out using rodent trials, cell-based assays, and advanced separation techniques.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.