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

这项小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力是预防和治疗糖尿病前期和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，相关的医疗费用超过3270亿美元。目前的治疗通常存在不良反应或对某些患者无效。预计到2024年，仅前五种人类糖尿病药物每年就将花费230亿美元。 该项目提出了一种新的糖尿病治疗方法，由有益肠道细菌的postbiotic混合物组成。这将改善糖尿病前期患者的临床结果。这一小型企业创新研究（SBIR）I期项目将评估有效性并阐明潜在的基于微生物组的治疗机制，以实现有效减少糖尿病相关标志物的口服治疗。三个技术目标是：1）评价该技术并证明与现有抗糖尿病药物相比具有等同或上级性能，2）更好地理解导致糖尿病前期和2型糖尿病治疗有效性的机制，以及3）从postbiotic混合物中鉴定活性分子。这些目标将通过啮齿动物试验、基于细胞的分析和先进的分离技术来实现。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。

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.