今天是:2019-08-22 星期四

注意缺陷多动障碍儿童的肠道菌群特点及与药物治疗相关性研究
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注册号:

Registration number:

ChiCTR1900023239 

最近更新日期:

Date of Last Refreshed on:

2019-05-18 

注册时间:

Date of Registration:

2019-05-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

注意缺陷多动障碍儿童的肠道菌群特点及与药物治疗相关性研究 

Public title:

Analysis of gut microbiota characteristics and drug therapy associations in children with attention-deficit hyperactivity disorder 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

注意缺陷多动障碍儿童的肠道菌群特点及与药物治疗相关性研究 

Scientific title:

Analysis of gut microbiota characteristics and drug therapy associations in children with attention-deficit hyperactivity disorder 

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:

王亚平 

研究负责人:

陈立 

Applicant:

Wang Yaping 

Study leader:

Chen Li 

申请注册联系人电话:

Applicant telephone:

+86 18883247798 

研究负责人电话:

Study leader's telephone:

+86 13677620103 

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:

18883247798@163.com 

研究负责人电子邮件:

Study leader's E-mail:

chenli2012@126.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:

重庆市渝中区中山二路136号 

研究负责人通讯地址:

重庆市渝中区中山二路136号 

Applicant address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China  

Study leader's address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, 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:

重庆医科大学附属儿童医院 

Applicant's institution:

Children’s Hospital of Chongqing Medical University 

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:

2019-59 

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:

重庆医科大学附属儿童医院医学研究伦理委员会 

Name of the ethic committee:

Approval Letter of the Institutional Review Board, Children’s Hospital of Chongqing Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-28 

伦理委员会联系人:

喻竹 

Contact Name of the ethic committee:

Yu Zhu 

伦理委员会联系地址:

重庆市渝中区中山二路136号 

Contact Address of the ethic committee:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China  

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 023-63664659 

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:

重庆医科大学附属儿童医院 

Primary sponsor:

Children's Hospital of Chongqing Medical University 

研究实施负责(组长)单位地址:

重庆市渝中区中山二路136号 

Primary sponsor's address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆医科大学附属儿童医院

具体地址:

渝中区中山二路136号

Institution
hospital:

Children's Hospital of Chongqing Medical University

Address:

136 Second Zhongshan Road, Yuzhong District

经费或物资来源:

自筹 

Source(s) of funding:

self-prepare 

研究疾病:

注意缺陷多动障碍 

Target disease:

Attention deficit hyperactivity disorder  

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

比较注意缺陷多动障碍(attention-deficit hyperactivity disorder,ADHD)患儿与正常儿童的肠道菌群差异,随访ADHD患儿服用盐酸哌甲酯1月余后肠道菌群变化情况。 

Objectives of Study:

To compare the difference of gut microbiota between children with attention deficit hyperactivity disorder (ADHD) and normal children, and investigate the changes of gut microbiota in ADHD children after taking methylphenidate hydrochloride (MPH).  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

ADHD组:经重庆医科大学附属儿童医院儿童保健科根据DSM-IV首次确诊为ADHD的儿童,且监护人同意患儿口服盐酸哌甲进行治疗。 对照组:正常儿童。 

Inclusion criteria

ADHD group: the children are first diagnosed with ADHD by healthcare departmentof Children's Hospital of Chongqing Medical University according to DSM-IV, and the children take methylphenidate hydrochloride after the informed consent is obtained from their guardians. control group; the normal chidren.  

排除标准:

ADHD组:①合并有神经系统器质性疾病、智力低下、焦抑郁、严重的心血管/消化系统疾病;②服用盐酸哌甲酯前1个月内及服用盐酸哌甲酯期间有急性或慢性感染性疾病者;③服用盐酸哌甲酯前1个月内及服用盐酸哌甲酯期间服用其他药物(特别是抗生素、微生态制剂)者;④不能连续服用盐酸哌甲酯至少1月者;⑤膳食因素(与菌群相关的)。 

Exclusion criteria:

ADHD group: ① with neurophysical diseases,mental retardation,anxiety,depression,serious cardiovascular disease, serious digestive system disease; ② acute and chronic infectious during the one month before taking methylphenidate hydrochloride and the period of taking methylphenidate hydrochloride; ③ taking other medicines,especially antibiotics and microbial ecological agents; ④ not continuous Administration of methylphenidate hydrochloride during one month; ⑤ dietary(related to gut microbiota). 

研究实施时间:

Study execute time:

From2019-06-01To 2020-12-31 

干预措施:

Interventions:

组别:

ADHD组

样本量:

20

Group:

ADHD group

Sample size:

干预措施:

干预措施代码:

Intervention:

no intervention

Intervention code:

组别:

正常儿童组

样本量:

20

Group:

Healthy chidren group

Sample size:

干预措施:

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:

中国 

省(直辖市):

重庆 

市(区县):

重庆 

Country:

China 

Province:

Chongqing 

City:

Chongqing 

单位(医院):

重庆医科大学附属儿童医院 

单位级别:

三级甲等 

Institution
hospital:

Children's Hospital of Chongqing Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

肠道菌群

指标类型:

主要指标 

Outcome:

gut microbiota

Type:

Primary indicator 

测量时间点:

测量方法:

16S rRNA

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

使用后保存 

说明

Fate of sample:

Preservation 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 years
最大 Max age 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):

病例对照研究,非随机化

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

Case-Control study, nonrandomized

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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):

发送邮件给研究负责人

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

send the email to the study leader

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:

病例记录表

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

Case Record Form

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-05-18
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