ChiCTR2300073432 版本V1.0 版本创建时间2023/07/11 10:05:18 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2300073432 

最近更新日期：

Date of Last Refreshed on：

 2023-07-11 10:05:11 

注册时间：

Date of Registration：

 2023-07-11 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

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

Public title：

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

注册题目简写：

English Acronym：

研究课题的正式科学名称：

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

Scientific title：

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

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Xuan Zhang 

研究负责人：

Bian Zhaoxiang 

Applicant：

Xuan Zhang 

Study leader：

Bian Zhaoxiang 

申请注册联系人电话：

Applicant telephone：

 +852 3411 2896

研究负责人电话：

Study leader's
telephone：

+852 3411 2905

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 zhangxuan@hkbu.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 bianzxiang@gmail.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

Room 307, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong, China

研究负责人通讯地址：

Room 307, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong, China

Applicant address：

Room 307, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong, China

Study leader's address：

Room 307, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

Hong Kong Baptist University

Applicant's institution：

Room 307, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong, China

研究负责人所在单位：

Hong Kong Baptist University

Affiliation of the Leader：

Room 307, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong, China

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 REC/21-22/0012;REC/21-22/0012-A1;REC/21-22/0012-A2

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Research Ethics Committee, Hong Kong Baptist University

Name of the ethic committee：

Research Ethics Committee, Hong Kong Baptist University

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-04-14 00:00:00

伦理委员会联系人：

Ms. Fiona Wong

Contact Name of the ethic committee：

Ms. Fiona Wong

伦理委员会联系地址：

Research Office, Hong Kong Baptist University, Kowloon Tong, Hong Kong

Contact Address of the ethic committee：

Research Office, Hong Kong Baptist University, Kowloon Tong, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3411 7941

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

Hong Kong Baptist University

Primary sponsor：

Hong Kong Baptist University

研究实施负责（组长）单位地址：

Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong, China

Primary sponsor's address：

Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

HKBU

具体地址：

host clinics and collaborative clinics of School of Chinese Medicine, Hong Kong Baptist University

Institution
hospital：

HKBU

Address：

host clinics and collaborative clinics of School of Chinese Medicine, Hong Kong Baptist University

经费或物资来源：

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

Source(s) of funding：

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

研究疾病：

Ulerative Colitis  

Target disease：

Ulerative Colitis

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

队列研究 

Study design：

Cohort study 

研究目的：

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

Objectives of Study：

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

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

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.

Inclusion criteria

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.

Exclusion criteria：

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.

研究实施时间：

Study execute time：

从 From 2022-11-01 00:00:00至 To 2025-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-05-01 00:00:00 至 To 2024-06-01 00:00:00

干预措施：

Interventions：

组别：

UC group

样本量：

 10

Group：

UC group

Sample size：

干预措施：

None

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 host clinics and collaborative clinics of School of Chinese Medicine, Hong Kong Baptist University 

单位级别：

 NA 

Institution
hospital：

host clinics and collaborative clinics of School of Chinese Medicine, Hong Kong Baptist University

Level of the institution：

NA

测量指标：

Outcomes：

指标中文名：

Tissue biopsy transcriptomes

指标类型：

主要指标

Outcome：

Tissue biopsy transcriptomes

Type：

Primary indicator

测量时间点：

Weeks 48 or experienced clinical remission more than 7 days

测量方法：

Measure time point of outcome：

Weeks 48 or experienced clinical remission more than 7 days

Measure method：

指标中文名：

serum inflammatory cytokines profiles

指标类型：

主要指标

Outcome：

serum inflammatory cytokines profiles

Type：

Primary indicator

测量时间点：

Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

测量方法：

Measure time point of outcome：

Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Measure method：

指标中文名：

Longitudinal variance in gut microbial over a year

指标类型：

主要指标

Outcome：

Longitudinal variance in gut microbial over a year

Type：

Primary indicator

测量时间点：

Weeks 0, 4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44 and 48

测量方法：

Measure time point of outcome：

Weeks 0, 4, 8, 12,16, 20, 24, 28, 32, 36, 40, 44 and 48

Measure method：

指标中文名：

Full Mayo score

指标类型：

次要指标

Outcome：

Full Mayo score

Type：

Secondary indicator

测量时间点：

week 0, and 48 or experienced clinical remission more than 7 days

测量方法：

Measure time point of outcome：

week 0, and 48 or experienced clinical remission more than 7 days

Measure method：

指标中文名：

Partial Mayo score

指标类型：

次要指标

Outcome：

Partial Mayo score

Type：

Secondary indicator

测量时间点：

Weeks 4, 8, 12,16, 20, 24, 28, 32, 36, 40, and 44

测量方法：

Measure time point of outcome：

Weeks 4, 8, 12,16, 20, 24, 28, 32, 36, 40, and 44

Measure method：

指标中文名：

IBD questionnaire (IBDQ)

指标类型：

次要指标

Outcome：

IBD questionnaire (IBDQ)

Type：

Secondary indicator

测量时间点：

At Weeks 0, and 48

测量方法：

Measure time point of outcome：

At Weeks 0, and 48

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

biopsy specimen of colon tissues

组织：

Sample Name：

biopsy specimen of colon tissues

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

标本中文名：

blood

组织：

Sample Name：

blood

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

NA

Randomization Procedure (please state who generates the random number sequence and by what method)：

NA

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

NA

Blinding：

NA

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

We will publish the protocol and share IPD data.

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

We will publish the protocol and share IPD data.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

Data submitted by the study candidates and enrolled participants on the mobile application MyCap will be stored in an encrypted database on the device and then synchronised to REDCap, a secure web application for building and managing online surveys and databases. Data collected during study visits, laboratory testing, endoscopy and sample analysis will all be uploaded to REDCap. All electronic data generated in this study will be stored in password-protected files on the university’s secure server. Hard copy files will be kept in locked cabinets in a secured building. Both electronic and hard copy files will only be accessible to authorised research personnel.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data submitted by the study candidates and enrolled participants on the mobile application MyCap will be stored in an encrypted database on the device and then synchronised to REDCap, a secure web application for building and managing online surveys and databases. Data collected during study visits, laboratory testing, endoscopy and sample analysis will all be uploaded to REDCap. All electronic data generated in this study will be stored in password-protected files on the university’s secure server. Hard copy files will be kept in locked cabinets in a secured building. Both electronic and hard copy files will only be accessible to authorised research personnel.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2023-07-11 10:05:11