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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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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