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Cohort study of irritable bowel syndrome
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注册号:

Registration number:

ChiCTR2100053563 

最近更新日期:

Date of Last Refreshed on:

2022-05-19 

注册时间:

Date of Registration:

2021-11-24 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

肠易激综合征专病队列研究 

Public title:

Cohort study of irritable bowel syndrome 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

肠易激综合征专病队列研究 

Scientific title:

Cohort study of irritable bowel syndrome 

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:

朱圣韬,武珊珊 

研究负责人:

张澍田,朱圣韬 

Applicant:

Zhu Shengtao, Wu Shanshan  

Study leader:

Zhang Shutian, Zhu Shengtao  

申请注册联系人电话:

Applicant telephone:

+86 13911313236 

研究负责人电话:

Study leader's telephone:

+86 13911313236 

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:

zhushengtao@ccmu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

zhushengtao@ccmu.edu.cn 

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:

北京市西城区永安路95号首都医科大学附属北京友谊医院 

研究负责人通讯地址:

北京市西城区永安路95号首都医科大学附属北京友谊医院 

Applicant address:

95 Yong'an Road, Xicheng District, Beijing 

Study leader's address:

95 Yong'an Road, Xicheng District, Beijing 

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:

首都医科大学附属北京友谊医院 

Applicant's institution:

Beijing Friendship Hospital Affiliated to Capital 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:

2021-P2-133-01 

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:

首都医科大学附属北京友谊医院伦理委员会 

Name of the ethic committee:

Beijing Friendship Hospital Affiliated to Capital Medical University Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-04-29 

伦理委员会联系人:

李悦 

Contact Name of the ethic committee:

Li Yue 

伦理委员会联系地址:

北京市西城区永安路95号首都医科大学附属北京友谊医院 

Contact Address of the ethic committee:

95 Yong'an Road, Xicheng District, Beijing 

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:

首都医科大学附属北京友谊医院 

Primary sponsor:

Beijing Friendship Hospital Affiliated to Capital Medical University 

研究实施负责(组长)单位地址:

北京市西城区永安路95号首都医科大学附属北京友谊医院  

Primary sponsor's address:

95 Yong'an Road, Xicheng District, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京友谊医院

具体地址:

西城区永安路95号

Institution
hospital:

Beijing Friendship Hospital, Capital Medical Univeristy

Address:

95 Yong'an Road, Xicheng District

经费或物资来源:

NA 

Source(s) of funding:

NA 

研究疾病:

肠易激综合征 

Target disease:

Irritable bowel syndrome (IBS) 

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 

研究目的:

1.评估IBS患者中抑郁/焦虑的患病率、睡眠质量、生活质量及内脏敏感性; 2.比较各IBS亚型中不同药物治疗方案的疗效及安全性; 3.探讨抑郁焦虑、睡眠质量、体育锻炼及内脏敏感程度对IBS疾病严重程度及疾病进展的影响; 4.探索潜在的IBS预后因子,包括肠道菌群、代谢组学、易感基因及炎症因子等指标; 5.比较IBS患者与正常健康对照者中肠道菌群、代谢组学及易感基因等指标的差异,从微观层面上为IBS的病因学探讨提供线索; 6.比较IBS患者与正常健康对照者中抑郁、焦虑、睡眠质量及内脏敏感性方面的差异,为IBS的病因学探讨提供可能的线索。 

Objectives of Study:

1. To assess the prevalence of depression/anxiety, sleep quality, quality of life and visceral sensitivity in IBS patients; 2. To compare the efficacy and safety of different drug regimens in each IBS subtype; 3. To explore the effects of depression and anxiety, sleep quality, physical exercise and visceral sensitivity on the severity and progression of IBS disease; 4. Explore potential IBS prognostic factors, including gut microbiota, metabolomics, susceptibility genes, and inflammatory factors; 5. To compare the differences in gut microbiota, metabolomics and susceptibility genes between IBS patients and normal healthy controls to provide clues for the etiology of IBS from the microscopic level; 6. To compare the differences in depression, anxiety, sleep quality and visceral sensitivity between IBS patients and normal healthy controls to provide possible clues for the etiology of IBS. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1.年龄在18岁以上; 2.符合罗马IV诊断标准; 3.两周内未使用任何解痉止痛药、胃肠动力药、抑酸剂、抗生素及非甾体抗炎类药物。 

Inclusion criteria

1. Aged over 18 years; 2. Meet the Rome IV diagnostic criteria; 3. No use of any antispasmodic analgesics, gastrointestinal motility drugs, acid suppressants, antibiotics and non-steroidal anti-inflammatory drugs within two weeks. 

排除标准:

1.合并心、肺、肾、脑、血液等重要脏器严重疾病患者; 2.合并严重精神疾病的患者(如抑郁症、躁狂症、癫痫发作、精神分裂症等); 3.合并消化系统及其他系统恶性肿瘤; 4.合并炎症性肠病、消化道溃疡、肠梗阻等器质性肠病患者; 5.合并乳糜泻、肠道感染、慢性胰腺炎、乳糖不耐受等其他消化系统疾病患者; 6.合并肝脏功能不全、肾脏功能不全等器质性疾病患者; 7.孕妇或哺乳期妇女; 8.研究者认为不能配合完成研究的患者。 

Exclusion criteria:

1. Patients with serious diseases of the heart, lung, kidney, brain, blood and other important organs; 2. Patients with severe mental illness (such as depression, mania, epilepsy, schizophrenia, etc.); 3. Combined with malignant tumors of digestive system and other systems; 4. Patients with organic bowel diseases such as inflammatory bowel disease, peptic ulcer, and intestinal obstruction; 5. Patients with celiac disease, intestinal infection, chronic pancreatitis, lactose intolerance and other digestive system diseases; 6. Patients with organic diseases such as liver insufficiency and renal insufficiency; 7. Pregnant or lactating patients; 8. Patients who, in the opinion of the investigator, cannot cooperate with the completion of the study. 

研究实施时间:

Study execute time:

From2021-12-01To 2026-06-30 

征募观察对象时间:

Recruiting time:

From2021-12-01To 2026-06-01 

干预措施:

Interventions:

组别:

IBS组

样本量:

2000

Group:

IBS group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

对照组

样本量:

1000

Group:

Control group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京友谊医院 

单位级别:

三甲 

Institution
hospital:

Beijing Friendship Hospital, Capital Medical Univeristy  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

3个月肠易激综合征患者IBS-SSS评分绝对值较基线下降≥50分的比例

指标类型:

主要指标 

Outcome:

Proportion of patients with IBS-SSS reduction>=50 at 3 months

Type:

Primary indicator 

测量时间点:

3个月

测量方法:

Measure time point of outcome:

3 months

Measure method:

指标中文名:

IBS-SSS 评分绝对值较基线下降≥50 分的比例

指标类型:

次要指标 

Outcome:

Proportion of absolute IBS-SSS score declines >=50 points from baseline

Type:

Secondary indicator 

测量时间点:

6 个月、12 个月、24 个月、36 个月、48 个月及 60 个月

测量方法:

Measure time point of outcome:

6 months, 12 months, 24 months, 36 months, 48 months and 60 months

Measure method:

指标中文名:

IBS-SSS 评分绝对值

指标类型:

次要指标 

Outcome:

Absolute IBS-SSS score

Type:

Secondary indicator 

测量时间点:

3 个月、6 个月、12 个月、24 个月、36 个月、48 个月及 60 个月

测量方法:

Measure time point of outcome:

3 months, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months

Measure method:

指标中文名:

Bristol 粪便量表评分

指标类型:

次要指标 

Outcome:

Bristol stool scale score

Type:

Secondary indicator 

测量时间点:

3 个月、6 个月、12 个月、24 个月、36 个月、48 个月及 60 个月

测量方法:

Measure time point of outcome:

3 months, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months

Measure method:

指标中文名:

排便频率改善情况

指标类型:

次要指标 

Outcome:

Improvement in bowel movements

Type:

Secondary indicator 

测量时间点:

3 个月、6 个月、12 个月、24 个月、36 个月、48 个月及 60 个月

测量方法:

Measure time point of outcome:

3 months, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months

Measure method:

指标中文名:

医院焦虑抑郁量表 HADS 评分

指标类型:

次要指标 

Outcome:

Hospital anxiety and depression scale HADS score

Type:

Secondary indicator 

测量时间点:

3 个月、6 个月、12 个月、24 个月、36 个月、48 个月及 60 个月

测量方法:

Measure time point of outcome:

3 months, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

尿液

组织:

Sample Name:

urine

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

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 18 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):

不涉及

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

NA

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

No

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):

NA

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

NA

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:

NA

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

NA

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-11-24
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