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【ChiCTR2300073432】A longitudinal observational study of the molecular dynamics and microbial profile in mediating relapse-remission in ulcerative colitis patients

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基本信息

登记号

ChiCTR2300073432

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2023-07-11

临床申请受理号

靶点

适应症

Ulerative Colitis

试验通俗题目

A longitudinal observational study of the molecular dynamics and microbial profile in mediating relapse-remission in ulcerative colitis patients

试验专业题目

A longitudinal observational study of the molecular dynamics and microbial profile in mediating relapse-remission in ulcerative colitis patients

申办单位信息

申请人联系人

申请人名称

联系人邮箱

联系人邮编

联系人通讯地址

临床试验信息

试验目的

1. To characterize the molecular signature, immune phenotypes and microbial components changes of ulcerative colitis (UC) patients over time. 2. To identify the potential relationship between immune activation and gut microbial components with the progression of remission-to-relapse in UC patients.

试验分类

试验类型

队列研究

试验分期

其它

随机化

N/A

盲法

N/A

试验项目经费来源

Health@InnoHK Initiative Fund of the Hong Kong Special Administrative Region Government (ITC RC/IHK/4/7)

试验范围

目标入组人数

实际入组人数

第一例入组时间

2022-11-01

试验终止时间

2025-01-01

是否属于一致性

入选标准

1. Aged 18-65 years; 2. Has previously diagnosed of ulcerative colitis; 3. Had colonoscopy with biopsy within 12months and full Mayo score > 3 (colonoscopy score < 3) before study entry; 4. Individuals should fully understand what is involved in this study and give documented consent to participate in the study.；

排除标准

Patients who meet one of the following criteria will be excluded: 1. Individual who unwilling to provide screening biopsy, blood or stool; 2. Individual who has been taken antibiotics or/and probiotics in the past one month; 3. Abnormal colonoscopy and biopsy pathology report, such as crypt epithelial dysplasia (intraepithelial neoplasia) or cancerous; 4. Intestinal stenosis; 5. Infectious enteritis or any suspicion of the presence of infectious enteritis (e.g., present of positive in the clostridium difficile test); 6. Laparotomy or laparoscopic surgery, surgery for hemorrhoids or perianal abscess, endoscopic mucosal resection or endoscopic intestinal dilation or endoscopic intestinal dilatation of the colon within 60 days before eligibility determination; 7. History of resection of the small intestine, cecum, colon or rectum; 8. Individuals with moderate or severe hepatic or renal disease or clinically significant bleeding disorder; 9. Individuals with any serious comorbid disease, such as hematological, respiratory, cardiovascular, or neuropsychiatric disease, or metabolic/electrolyte abnormality; 10. Individuals undergoing treatment or follow-up under 5 years for a malignant tumor; 11. History of alcohol or drug abuse; 12. Pregnant and nursing women and women suspected of being pregnant; 13. Individuals who are participating in any other clinical researches at study entry; 14. Others whom the investigator or co-investigator considered inappropriate for enrollment.；

研究者信息

研究负责人姓名

试验机构

Hong Kong Baptist University

研究负责人电话

研究负责人邮箱

研究负责人邮编

联系人通讯地址

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