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、发热和腹痛，通常对抗生素治疗具有耐药性。pCDI通常是先前暴露于抗生素的结果，这些抗生素破坏了我们肠道中健康微生物的平衡。粪便微生物群移植（FMT），从健康的筛选供体中引入健康的微生物群落，已被证明在经历CDI复发的患者中是安全和高效的，但在原发性感染中没有进行有力的测试。FMT还可以对抗可能存在于肠道中的其他有害微生物。由于FMT含有活细菌，因此需要冷冻保存直至给药。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的疗效。这种易于管理的产品将恢复健康的细菌群落，对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的感染的治疗。