中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2100051572
最近更新日期： Date of Last Refreshed on：	2021-09-27 05:25:52
注册时间： Date of Registration：	2021-09-27 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	腸道微生物組對專注力失調及過度活躍症（ADHD）的影響及其對鹽酸甲酯的反應：以中國南方人群為研究對象
Public title：	The role of gut microbiome in attention deficit hyperactivity disorder (ADHD) and its response to methylphenidate: A Southern Chinese study
注册题目简写：
English Acronym：
研究课题的正式科学名称：	腸道微生物組對專注力失調及過度活躍症（ADHD）的影響及其對鹽酸甲酯的反應：以中國南方人群為研究對象
Scientific title：	The role of gut microbiome in attention deficit hyperactivity disorder (ADHD) and its response to methylphenidate: A Southern Chinese study
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：	Ng Wai Yin	研究负责人：	Ng Wai Yin
Applicant：	Ng Wai Yin	Study leader：	Ng Wai Yin
申请注册联系人电话： Applicant telephone：	+852 35056959	研究负责人电话： Study leader's telephone：	+852 35056959
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：	ritang@cuhk.edu.hk	研究负责人电子邮件： Study leader's E-mail：	ritang@cuhk.edu.hk
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：	Department of Microbiology, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, New Territories, China, Hong Kong	研究负责人通讯地址：	Department of Microbiology, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, New Territories, China, Hong Kong
Applicant address：	Department of Microbiology, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, New Territories, China, Hong Kong	Study leader's address：	Department of Microbiology, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, New Territories, China, Hong Kong
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：	香港中文大學微生物學系
Applicant's institution：	Department of Microbiology/CUHK
研究负责人所在单位：	香港中文大學微生物學系
Affiliation of the Leader：	Department of Microbiology/CUHK

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：	2020.710	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：	香港中文大學--新界東醫院聯網臨床研究倫理聯席委員會
Name of the ethic committee：	Joint CUHK-NTEC Clinical Research Ethics Committee
伦理委员会批准日期： Date of approved by ethic committee：	2021-03-04 00:00:00
伦理委员会联系人：	Envy Lee
Contact Name of the ethic committee：	Envy Lee
伦理委员会联系地址：	中國香港特別行政區新界沙田銀城街威爾士親王醫院呂志和臨床醫學大樓8樓
Contact Address of the ethic committee：	8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, Hong Kong, China
伦理委员会联系人电话： Contact phone of the ethic committee：		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：

Department of Microbiology/CUHK

Primary sponsor：

Department of Microbiology/CUHK

研究实施负责（组长）单位地址：

中國香港特別行政區新界沙田銀城街威爾士親王醫院呂志和臨床醫學大樓微生物學系

Primary sponsor's address：

Department of Microbiology, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, New Territories, China, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中國	省(直辖市)：	香港特別行政區	市(区县)：
Country：	China	Province：	Hong Kong Special Administrative Region	City：
单位(医院)：	University Grants Committee	具体地址：	7/F., Shui On Centre, 6-8 Harbour Road, Wanchai
Institution hospital：	University Grants Committee	Address：	7/F., Shui On Centre, 6-8 Harbour Road, Wanchai

经费或物资来源：

HKSAR Government

Source(s) of funding：

HKSAR Government

研究疾病：

專注力失調及過度活躍症

Target disease：

ADHD

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：

连续入组

Study design：

Sequential

研究目的：

1. To identify the gut microbiota profile of ADHD cases and controls; 2. To identify the potential specific gut microbiome signature accounting for treatment response in ADHD patients on methylphenidate; 3. To compare the gut microbiome profile in ADHD patients with or without gastrointestinal side effects due to methylphenidate.

Objectives of Study：

1. To identify the gut microbiota profile of ADHD cases and controls; 2. To identify the potential specific gut microbiome signature accounting for treatment response in ADHD patients on methylphenidate; 3. To compare the gut microbiome profile in ADHD patients with or without gastrointestinal side effects due to methylphenidate.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

排除标准：

1. History of psychiatric diseases with any Diagnostic and Statistical Manual of Mental Disorder-V classification system (DSM-5) diagnosis including autism spectrum disorder, bipolar disorders, major depressive disorders, psychotic disorders;
2. History of neurological diseases including epilepsy, traumatic brain injury;
3. No major physical illnesses including intellectual disabilities;
4. Previous or current use of psychotropic medications including drugs for treatment of ADHD;
5. Currently taking antibiotics or probiotics;
6. History of inflammatory bowel disease, history of gastrointestinal cancer or major gastrointestinal surgery, and history of gastrointestinal infection within last 3 weeks;
7. Children with dietary habits including vegetarian.

Exclusion criteria：

1. History of psychiatric diseases with any Diagnostic and Statistical Manual of Mental Disorder-V classification system (DSM-5) diagnosis including autism spectrum disorder, bipolar disorders, major depressive disorders, psychotic disorders;
2. History of neurological diseases including epilepsy, traumatic brain injury;
3. No major physical illnesses including intellectual disabilities;
4. Previous or current use of psychotropic medications including drugs for treatment of ADHD;
5. Currently taking antibiotics or probiotics;
6. History of inflammatory bowel disease, history of gastrointestinal cancer or major gastrointestinal surgery, and history of gastrointestinal infection within last 3 weeks;
7. Children with dietary habits including vegetarian.

研究实施时间：

Study execute time：

从 From 2021-10-01 00:00:00至 To 2024-09-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2021-10-01 00:00:00 至 To 2024-09-30 00:00:00

干预措施：

Interventions：

组别：	Two groups	样本量：	320
Group：	2 groups	Sample size：	320
干预措施：	Nil	干预措施代码：
Intervention：	Nil	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)：	威爾士親王醫院	单位级别：	三甲医院
Institution hospital：	Prince of Wales Hospital	Level of the institution：	Tertiary A Hospital

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)：	雅麗氏何妙齡那打素醫院	单位级别：	三甲医院
Institution hospital：	Alice Ho Miu Ling Nethersole Hospital	Level of the institution：	Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：	gut microbiome	指标类型：	主要指标
Outcome：	gut microbiome	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	粪便	组织：
Sample Name：	Stool	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

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	6	岁 years
最大 Max age	18	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）：

N/A

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

N/A

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：	N/A
Blinding：	N/A
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	will be through publications and presentations at conferences relevant to the speciality. We aim to publish the findings in peer reviewed journals
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	will be through publications and presentations at conferences relevant to the speciality. We aim to publish the findings in peer reviewed journals
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 collection and management: All data management will be undertaken by the Prince of Wales Hospital. Standard operating procedures will be in place for the collection and handling of data received at the unit. All study data will be entered into a secure electronic trial database with restricted access. Data will be collected on the data collection forms and entered into the electronic database which will only identify the participants by a unique trial number.
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Data collection and management: All data management will be undertaken by the Prince of Wales Hospital. Standard operating procedures will be in place for the collection and handling of data received at the unit. All study data will be entered into a secure electronic trial database with restricted access. Data will be collected on the data collection forms and entered into the electronic database which will only identify the participants by a unique trial number.
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：	2021-09-27 05:25:52