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

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，通常对抗生素治疗有耐药性。pCDI通常是以前接触抗生素的结果，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），即从健康的筛选供体中引入健康的微生物群落，已被证明对CDI复发的患者是安全和高效的，但在原发性感染中尚未得到有力的测试。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，所以在给药前需要冷冻。我们已经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感染的治疗方法。

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.