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-猫眼课题宝

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

项目类别：

财政年份：

资助国家：

美国

项目状态：

未结题

起止时间：

至

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

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项目成果

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中文摘要

翻译

在2023财政年度，临床试验在获得所有批准后开始登记（美国国立卫生研究院机构审查委员会#000809和美国食品和药物管理局研究新药申请#28209）。3例慢性肉芽肿性结肠炎患者成功接受粪便菌群移植。迄今为止，已有两名受试者完成了试验。安全监察委员会每6个月召开一次会议。该试验将在2024财政年度继续招募。

英文摘要

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.

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