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

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/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糖尿病前期或2型糖尿病，相关的医疗费用超过3270亿美元。目前的治疗方法在一些患者中经常出现不良反应或无效。预计到2024年，仅排名前五的人类糖尿病药物每年的成本就将达到230亿美元。这个项目提出了一种新的糖尿病治疗方法，它由有益的肠道细菌组成的生后混合物组成。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)第一阶段项目将评估基于微生物组的潜在治疗方法的有效性并阐明其机制，以期获得有效降低糖尿病相关标志物的口服治疗方法。三个技术目标是：1)评估技术并展示与现有抗糖尿病药物同等或更好的性能；2)更好地了解导致治疗糖尿病前期和2型糖尿病有效的机制；以及3)从生物后混合物中识别活性分子(S)。这些目标将使用啮齿动物试验、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智力优势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.