LYOPHILIZED FECAL MICROBIOME TRANSFER FOR PRIMARY CLOSTRIDIOIDES DIFFICILE INFECTION (DONATE STUDY): A MULTICENTER RANDOMIZED CONTROLLED TRIAL

用于原发性艰难梭菌感染的冻干粪便微生物组转移（捐赠研究）：多中心随机对照试验

• 批准号: MR/X031624/1
• 负责人: Benjamin Harvey Mullish
• 金额: $ 19.31万
• 依托单位: Imperial College London
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FX031624%2F1
• 关键词: LYOPHILIZED; FECAL; MICROBIOME; TRANSFER; PRIMARY

Primary Clostridioides difficile infection (pCDI) is a gastrointestinal infection that presents with diarrhea , fever and abdominal pain and is often resistant to antibiotic therapy. pCDI is often a consequence of previous exposure to antibiotics that disrupt the balance of healthy microbes that reside in our gut. Fecal microbiota transplantation (FMT), the introduction of a healthy microbial community from a healthy screened donor, has been shown to be safe and highly effective in patients who experience recurrence of CDI, but was not vigorously tested in primary infection. FMT can also fight other deleterious microbes that might reside in the gut. Since FMT contains live bacteria, it needs to be kept frozen until administration. We have developed a dry compound that does not need freezing (Lyo-FMT) and aim to assess its efficacy for pCDI. This easy-to-administer product will restore the healthy bacterial community, fight infection and reduce the use of antibiotics. If effective, this study will revolutionise the treatment of this worldwide distributed infection.

原发性艰难梭菌感染 (pCDI) 是一种胃肠道感染，表现为腹泻、发烧和腹痛，并且通常对抗生素治疗产生耐药性。 pCDI 通常是先前接触抗生素的结果，抗生素破坏了肠道内健康微生物的平衡。粪便微生物群移植 (FMT) 是从健康筛选的捐赠者那里引入健康的微生物群落，已被证明对于经历 CDI 复发的患者是安全且高效的，但尚未在原发感染中进行严格测试。 FMT 还可以对抗肠道中可能存在的其他有害微生物。由于 FMT 含有活细菌，因此在给药前需要保持冷冻状态。我们开发了一种不需要冷冻的干燥化合物 (Lyo-FMT)，旨在评估其对 pCDI 的功效。这种易于使用的产品将恢复健康的细菌群落，抵抗感染并减少抗生素的使用。如果有效，这项研究将彻底改变这种全球分布感染的治疗方法。