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Fecal Microbiota Transplant for C. difficile Infection in Solid Organ Transplant Recipients

实体器官移植受者粪便微生物群移植治疗艰难梭菌感染

基本信息

批准号：
10462715
负责人：
NASIA SAFDAR
金额：
$ 102.21万
依托单位：
UNIVERSITY OF WISCONSIN-MADISON
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-09-15 至 2023-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10462715
关键词：
Abdomen Address Adult Antibiotics Attention Blood specimen Centers for Disease Control and Prevention (U.S.)Cessation of life Characteristics Clinic Visits Clinical Services Clinical Trials Clostridium difficile Colitis Colonoscopy Comparative Study Country Data Devices Diarrhea Double-Blind Method Duodenum Equilibrium Etiology Exposure to Feces Freezing Goals Guidelines Health Healthcare Immunity Immunosuppression Impairment Incidence Individual Infection Infusion procedures Inpatients Institution Intervention Intestines Knowledge Medical Operative Surgical Procedures Oral Organ Transplantation Outcome Patients Population Prevention Procedures Public Health Quality of life Randomized Randomized Controlled Trials Recurrence Relapse Reporting Research Risk Role Safety Site Solid Structure Testing Therapeutic Time Transplantation Treatment Failure Vancomycin Vancomycin resistant enterococcus adverse outcome antibiotic-associated diarrhea bacterial community comorbidity cost design disorder later incidence prevention effective therapy efficacy study end-stage organ failure enema administration fecal transplantation follow-up gut colonization gut dysbiosis gut microbiome gut microbiota human old age (65+)improved innovation interest microbiota mortality multi-drug resistant pathogen novel novel strategies organ transplant recipient pathogen placebo controlled trial prevent primary endpoint programs recurrent infection restoration safety outcomes secondary outcome side effect standard of care stool sample study population treatment as usual

项目摘要

Abstract Clostridium difficile is the most frequent bacterial cause of antibiotic-associated diarrhea. Solid organ transplant recipients have a higher rate of C. difficile infection (CDI), and greater risk for adverse consequences because of immunosuppression, frequent antibiotic use and medical procedures all of which disrupt the normal gut microbiota. Dysbiosis of the gut microbiota predisposes to CDI which, despite treatment can recur in 30% of patients. A novel way to prevent CDI recurrence is by instilling feces from a healthy individual into the intestine of the CDI patient, thereby restoring balance in the gut microbiota. However, it is unknown whether or not fecal microbiota transplantation (FMT) is an efficacious choice for CDI recurrence prevention in SOT recipients. We propose a randomized, double-blind double-dummy placebo-controlled trial at five sites comparing FMT with oral vancomycin for 158 SOT recipients with at least a first but no more than 3 recurrences of CDI. We will collect fecal and blood samples from subjects prior to and after FMT and collect data on recurrence, CDI-related quality of life, microbiota composition and function. The trial's primary endpoint is recurrent CDI in the 60-day time frame following completion of treatment. Secondary outcomes are safety and gut microbiota characteristics. Each subject will contribute 6 stool samples, 3 blood samples and will have 6 clinic visits. Total duration of follow-up will be 24 weeks per subject. The FMT will be administered via enema using frozen stool from universal donors. By following patients for 6 months, we will determine whether FMT successfully and safely reduces recurrence of CDI and improves other outcomes in SOT recipients with CDI.

抽象的艰难梭菌是抗生素相关性腹泻最常见的细菌原因。坚硬的器官移植受者的艰难梭菌感染率 (CDI) 较高，并且发生感染的风险也较高由于免疫抑制、频繁使用抗生素和医疗造成的不良后果所有这些程序都会破坏正常的肠道微生物群。肠道菌群失调易患 CDI，尽管接受治疗，仍有 30% 的患者会复发。一种新颖的方式预防 CDI 复发的方法是将健康人的粪便注入患者的肠道 CDI 患者，从而恢复肠道微生物群的平衡。然而，尚不清楚是否或非粪便微生物群移植 (FMT) 是预防 CDI 复发的有效选择在 SOT 接收者中。我们提出了一种随机、双盲、双模拟安慰剂对照的方法在五个地点进行的试验，对 158 名 SOT 接受者进行了 FMT 与口服万古霉素的比较，其中至少有第一个但 CDI 复发次数不超过 3 次。我们将从受试者身上收集粪便和血液样本 FMT 之前和之后，收集有关复发、CDI 相关生活质量、微生物群的数据组成和功能。该试验的主要终点是 60 天时间范围内的复发性 CDI 治疗完成后。次要结果是安全性和肠道微生物群特征。每个受试者将提供 6 份粪便样本、3 份血液样本，并有 6 诊所就诊。每个受试者的总随访时间为 24 周。 FMT 将是使用来自通用捐赠者的冷冻粪便进行灌肠。通过跟踪患者 6 几个月后，我们将确定 FMT 是否成功、安全地减少 CDI 复发，改善患有 CDI 的 SOT 接受者的其他结果。