A pilot study of fecal microbiota transplantation for Chronic Granulomatous Disorder Associated Colitis (CGD-AC)

粪便微生物群移植治疗慢性肉芽肿性疾病相关结肠炎 (CGD-AC) 的初步研究

• 批准号: 10927992
• 负责人: Suchitra Hourigan
• 金额: $ 55.77万
• 依托单位: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10927992
• 关键词: Antibiotic Resistance; Biological Products; Chronic; Chronic Granulomatous Disease; Clinical; Clinical Trials; Colitis; Colonoscopy; Data; Disease; Enrollment; Evaluation; Granulomatous disease; Immune system; Immunomodulators; Inflammation; Inflammatory Bowel Diseases; Inherited; Institutional Review Boards; Investigational New Drug Application; Investigational Therapies; Leukocyte L1 Antigen Complex; Measures; Monitor; Participant; Pharmaceutical Preparations; Pilot Projects; Population; Randomized, Controlled Trials; Risk; Safety; Signal Transduction; Site; Symptoms; United States Food and Drug Administration; United States National Institutes of Health; arm; associated symptom; congenital immunodeficiency; design; effective therapy; fecal microbiome; fecal transplantation; gut dysbiosis; gut inflammation; gut microbiota; improved; meetings; microbiome; open label; pilot trial; prospective; systemic inflammatory response

During the fiscal year 2023, the clinical trial started enrollment after all approvals were obtained (National Institutes of Health Institutional Review Board #000809 and U.S. Food and Drug Administration Investigational New Drug application #28209). Three subjects with Chronic Granulomatous Disease associated colitis have successfully received fecal microbiota transplantation. Two subjects have completed the trial to date. Safety monitoring committee meetings have been held every 6 months. The trial will continue to enroll during the fiscal year 2024.

在2023年财政年度，临床试验在获得所有批准后开始登记(国家卫生研究院机构审查委员会000809号和美国食品和药物管理局调查性新药申请28209号)。三名患有慢性肉芽肿性疾病相关性结肠炎的患者成功地接受了粪便微生物群移植。到目前为止，已经有两名受试者完成了试验。安全监督委员会每6个月召开一次会议。该试验将在2024财年继续进行。