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Hong Kong Gut Microbiota Databank
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注册号:

Registration number:

ChiCTR1900021159 

最近更新日期:

Date of Last Refreshed on:

2019-01-30 

注册时间:

Date of Registration:

2019-01-30 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

香港人腸道微生物群資料庫 

Public title:

Hong Kong Gut Microbiota Databank 

注册题目简写:

港人腸菌圖譜 

English Acronym:

HKGutMicMap 

研究课题的正式科学名称:

建立香港腸道微生物群全面資料庫並識別與腸道微生物群圖譜相關的流行病學及健康因素 

Scientific title:

Establish a Comprehensive Gut Microbiota Databank and Identify Epidemiological and Health Factors Associated with Gut Microbial Community Profiles in Hong Kong 

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:

Prof. Paul KS Chan 

研究负责人:

Prof. Paul KS Chan 

Applicant:

Prof. Paul KS Chan 

Study leader:

Prof. Paul KS Chan 

申请注册联系人电话:

Applicant telephone:

+852 35053339 

研究负责人电话:

Study leader's telephone:

+852 35053339 

申请注册联系人传真 :

Applicant Fax:

+852 26473227 

研究负责人传真:

Study leader's fax:

+852 26473227 

申请注册联系人电子邮件:

Applicant E-mail:

paulkschan@cuhk.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

paulkschan@cuhk.edu.hk 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.cuhk.edu.hk/med/mic/People/Paul.html 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

http://www.cuhk.edu.hk/med/mic/People/Paul.html 

申请注册联系人通讯地址:

中國香港沙田威爾斯親王醫院呂志和臨床科學大樓1樓  

研究负责人通讯地址:

中國香港沙田威爾斯親王醫院呂志和臨床科學大樓1樓  

Applicant address:

Department of Microbiology, 1/F LCW Clinical Sciences Building, Prince of Wales Hospital, Shatin, NT., Hong Kong SAR, China  

Study leader's address:

Department of Microbiology, 1/F LCW Clinical Sciences Building, Prince of Wales Hospital, Shatin, NT., Hong Kong SAR, China  

申请注册联系人邮政编码:

Applicant postcode:

000 

研究负责人邮政编码:

Study leader's postcode:

000 

申请人所在单位:

香港中文大學 

Applicant's institution:

The Chinese University of Hong Kong  

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:

2018.383 

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:

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee 

Name of the ethic committee:

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-11-23 

伦理委员会联系人:

Miss Envy Lee 

Contact Name of the ethic committee:

Miss Envy Lee 

伦理委员会联系地址:

中國香港沙田威爾斯親王醫院呂志和臨床科學大樓8樓 

Contact Address of the ethic committee:

8/F, LCW Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong SAR, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+852 35053935 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

crec@cuhk.edu.hk 

研究实施负责(组长)单位:

香港中文大學 

Primary sponsor:

The Chinese University of Hong Kong 

研究实施负责(组长)单位地址:

中國香港沙田威爾斯親王醫院呂志和臨床科學大樓1樓 

Primary sponsor's address:

Department of Microbiology, 1/F LCW Clinical Sciences Building, Prince of Wales Hospital, Shatin, NT., Hong Kong SAR, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

香港中文大學 

Source(s) of funding:

The Chinese University of Hong Kong  

研究疾病:

Study on general population. No specific target disease  

Target disease:

Study on general population. No specific target disease  

研究疾病代码:

Not applicable 

Target disease code:

Not applicable 

研究类型:

流行病学研究 

Study type:

Epidemilogical research 

研究所处阶段:

基础科学研究 

Study phase:

Basic Science 

研究目的:

This study aims at understanding the structure and characteristics of the gut microbiota and their epidemiological and health correlations in the general population in Hong Kong. This information is fundamental to future developments in using gut microbiota modulation as means to improve human health and to manage diseases.  

Objectives of Study:

This study aims at understanding the structure and characteristics of the gut microbiota and their epidemiological and health correlations in the general population in Hong Kong. This information is fundamental to future developments in using gut microbiota modulation as means to improve human health and to manage diseases.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

No treatment intervention. 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

1. Chinese living in Hong Kong for more than 3 years; 2. Aged 18 or above, no upper age limit. 

Inclusion criteria

1. Chinese living in Hong Kong for more than 3 years; 2. Aged 18 or above, no upper age limit. 

排除标准:

1. Subjects who are unable to give consent or who have conditions rendering them incapable to answer questionnaires or provide samples. 

Exclusion criteria:

1. Subjects who are unable to give consent or who have conditions rendering them incapable to answer questionnaires or provide samples. 

研究实施时间:

Study execute time:

From2019-02-15To 2026-02-14 

征募观察对象时间:

Recruiting time:

From2019-02-15To 2021-02-14 

干预措施:

Interventions:

组别:

Population

样本量:

3720

Group:

Population

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

No intervention

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中國 

省(直辖市):

香港特別行政區 

市(区县):

 

Country:

China 

Province:

Hong Kong SAR 

City:

 

单位(医院):

The Chinese University of Hong Kong 

单位级别:

大学 

Institution
hospital:

The Chinese University of Hong Kong  

Level of the institution:

University 

测量指标:

Outcomes:

指标中文名:

Microbiota characteristics including structure, constituent, community profile and function in associate with epidemiological and health conditions.

指标类型:

主要指标 

Outcome:

Microbiota characteristics including structure, constituent, community profile and function in associate with epidemiological and health conditions.

Type:

Primary indicator 

测量时间点:

cross-sectional at enrollment

测量方法:

sequencing and bioinformatics

Measure time point of outcome:

cross-sectional at enrollment

Measure method:

sequencing and bioinformatics

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

Stool

组织:

Sample Name:

Stool

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

15 years

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:

15 years

标本中文名:

oral cavity swabs

组织:

Sample Name:

oral cavity swabs

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

15 years

标本中文名:

skin swabs

组织:

Sample Name:

skin swabs

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

15 years

标本中文名:

nasal swabs

组织:

Sample Name:

nasal swabs

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

15 years

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 100 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):

N/A

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

N/A

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

shared via institutional platforms

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

shared via institutional platforms

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:

1. A standard questionnaire will be used to collection anthropometric, epidemiological, medical, psychological, social and health information (GutMicrobe_Medical and health questionnaire). Participants are required to fill in a hard copy by hand or via an online electronic system. These information will be collected at enrollment and once again during the follow-up at 5 years later. 2. A standard collection form will be used to collection information concerning the 3 days prior to stool sample collection. 3. Information derived from testing of samples will be used for study analysis. These include lipid profile, glucose and HbA1c, as well as other biomarkers that may be included in the future. 4. Medical information of subjects may be retrieved from the Clinical Management System of Hospital Authority.

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

1. A standard questionnaire will be used to collection anthropometric, epidemiological, medical, psychological, social and health information (GutMicrobe_Medical and health questionnaire). Participants are required to fill in a hard copy by hand or via an online electronic system. These information will be collected at enrollment and once again during the follow-up at 5 years later. 2. A standard collection form will be used to collection information concerning the 3 days prior to stool sample collection. 3. Information derived from testing of samples will be used for study analysis. These include lipid profile, glucose and HbA1c, as well as other biomarkers that may be included in the future. 4. Medical information of subjects may be retrieved from the Clinical Management System of Hospital Authority.

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-01-30
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