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肠道菌群与儿童和青少年精神疾病的相关性研究
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注册号:

Registration number:

ChiCTR1900024396 

最近更新日期:

Date of Last Refreshed on:

2019-07-10 

注册时间:

Date of Registration:

2019-07-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

肠道菌群与儿童和青少年精神疾病的相关性研究 

Public title:

Correlation between gut microbiota and psychiatric disorders in children and adolescents 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

肠道菌群与儿童和青少年精神疾病的相关性研究 

Scientific title:

Correlation between gut microbiota and psychiatric disorders in children and adolescents 

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:

蒋海寅 

研究负责人:

蒋海寅 

Applicant:

Haiyin Jiang 

Study leader:

Haiyin Jiang 

申请注册联系人电话:

Applicant telephone:

+86 13758117634 

研究负责人电话:

Study leader's telephone:

+86 13758117634 

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:

jianghaiyin@126.com 

研究负责人电子邮件:

Study leader's E-mail:

jianghaiyin@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:

浙江省杭州市庆春路79号 

研究负责人通讯地址:

浙江省杭州市庆春路79号 

Applicant address:

79 Qingchun Road, Hangzhou, Zhejiang 

Study leader's address:

79 Qingchun Road, Hangzhou, Zhejiang 

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:

浙江大学医学院附属第一医院 

Applicant's institution:

The First Affiliated Hospital, College of Medicine, Zhejiang 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:

2019-1034 

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:

浙江大学医学院附属第一医院科研伦理委员会 

Name of the ethic committee:

Research Ethics Committee of the First Affiliated Hospital, College of Medicine, Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-07-08 

伦理委员会联系人:

殷琳 

Contact Name of the ethic committee:

Yin Lin 

伦理委员会联系地址:

浙江省杭州市庆春路79号浙江大学医学院附属第一医院17号楼3楼 

Contact Address of the ethic committee:

3rd Floor, Building 17, 79 Qingchun Road, Hangzhou, Zhejiang 

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:

浙江大学医学院附属第一医院 

Primary sponsor:

The First Affiliated Hospital, College of Medicine, Zhejiang University 

研究实施负责(组长)单位地址:

浙江省杭州市庆春路79号 

Primary sponsor's address:

79 Qingchun Road, Hangzhou, Zhejiang 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江大学医学院附属第一医院

具体地址:

庆春路79号

Institution
hospital:

The First Affiliated Hospital, College of Medicine, Zhejiang University

Address:

79 Qingchun Road

国家:

中国

省(直辖市):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

杭州市第七人民医院

具体地址:

天目山路305号

Institution
hospital:

Hangzhou Seventh People’s Hospital

Address:

305 Tianmushan Road

国家:

中国

省(直辖市):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

杭州市第一人民医院

具体地址:

浣纱路261号

Institution
hospital:

Hangzhou First People’s Hospital

Address:

261 Huansha Road

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

National Natural Science Foundation of China 

研究疾病:

精神障碍 

Target disease:

Psychiatric disorders 

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:

探索性研究/预试验 

Study phase:

研究目的:

肠道菌群在人体健康中的重要作用越来越多的被认识,以无创性的肠道菌群作为疾病干预治疗的靶标已成为目前研究的热点。大脑和肠道菌群的联系提示肠道菌群可能是精神疾病的诱因之一。研究儿童及青少年精神疾病患者肠道菌群对于筛选关键致病菌,并为开发特定的儿童及青少年精神疾病微生态制剂以及靶向药物提供重要参考。 

Objectives of Study:

The importance of gut microbiota in human health has been recognized,and targeting the microbiota as therapeutic strategy has became the research hotspot.The bidirectional connection between gut microbiota and brain prompts the microbiota may be the direct cause of some mental diseases. According to the study, we will understand the role of specific gut microbes in the development of mental disorders, which will screen out the disease-associated key functional bacteria and provide a scientific basis for the prevention and treatment of mental disorders in children and adolescents. 

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:

① 年龄5周岁至18周岁; ② 符合《中国精神障碍分类与诊断标准》中的抑郁症,双相情感障碍,精神分裂症及焦虑症诊断标准; ③ 患者自愿参与研究,并签署知情同意书。  

Inclusion criteria

1. Aged 5 to 18 years; 2. Comply with the diagnostic criteria for Alzheimer's disease in the Classification and Diagnostic Criteria of Chinese Mental Disorders; 3. Patients volunteered to participate in the study and signed informed consen. 

排除标准:

① 躯体疾病引发精神障碍者;颅脑 CT及 MRI显示存在颅脑占位性病变及感染者。 ② BMI>24;肥胖;脂肪肝;过敏性疾病; ③ 近1月内服用抗生素及微生态制剂及激素类药物; ④ 近4周内有腹泻病或其他胃肠道疾病史; ⑤ 既往有胃肠道手术史。 

Exclusion criteria:

1. Physical illness caused by mental disorders;brain CT and MRI showed brain lesions and infection; 2. BMI>24; obesity; steatohepatitis; allergic disease; 3. Take antibiotics and microecological preparations and hormone drugs in the past 1 month; 4. With a history of diarrheal disease or other gastrointestinal diseases in the past 4 weeks; 5. With a history of gastrointestinal surgery. 

研究实施时间:

Study execute time:

From2019-07-01To 2021-07-01 

干预措施:

Interventions:

组别:

精神障碍组

样本量:

300

Group:

Psychiatric disorder group

Sample size:

干预措施:

干预措施代码:

Intervention:

No

Intervention code:

组别:

健康一级亲属组

样本量:

150

Group:

Health first-degree relative group

Sample size:

干预措施:

干预措施代码:

Intervention:

No

Intervention code:

组别:

健康对照组

样本量:

150

Group:

Health control group

Sample size:

干预措施:

干预措施代码:

Intervention:

No

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江大学医学院附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital, College of Medicine, Zhejiang University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

杭州市第七人民医院 

单位级别:

三级甲等 

Institution
hospital:

Hangzhou Seventh People’s Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

杭州市第一人民医院 

单位级别:

三甲 

Institution
hospital:

Hangzhou First People’s Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

操作分类单元

指标类型:

主要指标 

Outcome:

OTU

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:

肠道

Sample Name:

Fecas

Tissue:

intestinal tract

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 5 years
最大 Max age 18 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):

对患有精神障的儿童和青少年患者(n=300),其健康一级亲属(n=150)和年龄与性别匹配的对照组参与者(n=150)收集的粪便样品进行肠道微生物组成分析。

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

Analysis of intestinal microbial composition in stool samples from Participants hospitalized with psychiatric disorders (n = 300), their health first-degree relatives (n = 150) and age-and gender-matched control participants(n = 150).

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):

Resman, http://www.medresman.org

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

ResMan, http://www.medresman.org

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:

电子管理系统

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

Electronic Data Capture

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-07-10
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