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幽门螺杆菌感染及根除治疗对胃内菌群的影响
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注册号:

Registration number:

ChiCTR1900024893 

最近更新日期:

Date of Last Refreshed on:

2019-08-02 

注册时间:

Date of Registration:

2019-08-02 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

幽门螺杆菌感染及根除治疗对胃内菌群的影响 

Public title:

Effect of Helicobacter pylori infection and eradication therapy on gastric microbiota 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

幽门螺杆菌感染及根除治疗对胃内菌群的影响 

Scientific title:

Effect of Helicobacter pylori infection and eradication therapy on gastric microbiota 

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:

原子英 

研究负责人:

周丽雅 

Applicant:

Ziying YUAN 

Study leader:

Liya ZHOU 

申请注册联系人电话:

Applicant telephone:

+86 17812085156 

研究负责人电话:

Study leader's telephone:

+86 15611908239 

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:

290694010@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

zhoumed@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:

北京市海淀区花园北路49号 

研究负责人通讯地址:

北京市海淀区花园北路49号 

Applicant address:

49 North Huayuan Road, Haidian District, Beijing, China 

Study leader's address:

49 North Huayuan Road, Haidian District, Beijing, 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:

北京大学第三医院 

Applicant's institution:

Peking University Third Hospital 

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)医伦审第(130-02)号 

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:

北京大学第三医院医学科学研究伦理委员会 

Name of the ethic committee:

Medical Scientific Research EC of Peking University Third Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

洪雪 

Contact Name of the ethic committee:

Xue HONG 

伦理委员会联系地址:

北京市海淀区花园北路49号 

Contact Address of the ethic committee:

49 North Garden Road, Haidian District, Beijing, 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:

北京大学第三医院消化科 

Primary sponsor:

Department of Gastroenterology, Peking University Third Hospital 

研究实施负责(组长)单位地址:

北京市海淀区花园北路49号 

Primary sponsor's address:

49 North Garden Road, Haidian District, Beijing, 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):

北京市

市(区县):

北京市

Country:

China

Province:

Beijing

City:

Beijing

单位(医院):

北京大学第三医院

具体地址:

北京市海淀区花园北路49号

Institution
hospital:

Peking University Third Hospital

Address:

49 Huanyuan Road North, Haidian Distric, Beijing, China

经费或物资来源:

主要研究者横向综合经费 

Source(s) of funding:

Principal Investigator Horizontal Funding 

研究疾病:

幽门螺杆菌感染 

Target disease:

Helicobacter pylori infection 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

主要目的:探究H.pylori(+)患者根除治疗前后胃内菌群结构变化。 次要目的:1)探究无症状志愿者中H.pylori(+)和H.pylori(-)者的胃内菌群结构特点及其差异。2)探究因上腹不适等症状就诊患者中H.pylori(+)和H.pylori(-)者的胃内菌群结构特点及其差异。3)探究幽门螺杆菌根除联合益生菌补充对胃内菌群影响。 

Objectives of Study:

The primaty objective: To explore the changes of gastric microbiota structure in patients with H.pylori infection before and after eradication therapy. Secondary objectives: 1) To explore the structural characteristics and differences of gastric microbioba in H.pylori(+) and H.pylori(-) asymptomatic volunteers; 2) To explore the structural characteristics and differences of gastric microbiota in H.pylori(+) and H.pylori(-) patients with upper abdominal discomfort; 3) To explore the effect of quadruple eradication therapy combined with probiotic supplementation on the gastric microbiota. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.男女不限,年龄在18-30岁之间; 2.招募无症状志愿者或因上腹不适等症状就诊于北京大学第三医院的患者; 3.一般情况好,神志清; 4.工作、生活、饮食规律; 5.无呼吸、循环、泌尿、血液、内分泌等系统性疾病; 6.无感染、外伤和肿瘤; 7.受试者为有能力理解本次临床试验特征的有完全民事行为的人,同意参与本项研究,并自愿签署知情同意书。 

Inclusion criteria

1. Male or female aged 18 to 30 years old; 2. Asymptomatic volunteers,or patients who come to Peking University third hospital due to epigastric discomfort; 3. Volunteers or patients who are mentally clear and with good general situation; 4. Have regular work and eating habits; 5. No systemic diseases such as respiratory, circulatory, urinary, blood and endocrine diseases; 6. No infection, trauma or tumor; 7. Subjects who are capable of understanding the characteristics of this clinical trial and have full capacity for civil acts, agree to participate in this study and sign the informed consent voluntarily. 

排除标准:

1.怀孕和哺乳期妇女或近半年内有备孕需求者; 2.既往幽门螺杆菌根除史、消化道疾病史及手术史; 3.近一个月内服用NSAIDs、抗生素、黏膜保护剂、免疫抑制剂、益生菌、抑酸药物; 4.长期吸烟或饮酒患者; 5.内镜下发现有胆汁反流、溃疡和息肉等病变者; 6.病理检查发现伴萎缩、伴肠化、伴异型增生、肿瘤者; 7.近3个月内参加过或正在参加其它临床试验者。 

Exclusion criteria:

1. Pregnant and lactating women or those with pregnancy needs in next six months; 2. Previous history of Helicobacter pylori eradication, digestive tract diseases and surgery; 3. Taking NSAIDs, antibiotics, mucosal protective agent, immunosuppressants, probiotics and acid-inhibiting drugs within one month; 4. Long-term smoking or drinking patients; 5. Endoscopic findings of bile reflux, ulcers and polyps; 6. Histopathological findings of atrophy, intestinal metaplasia, dysplasia, and tumor; 7. People who have participated in other clinical trials in the past 3 months. 

研究实施时间:

Study execute time:

From2019-09-02To 2021-03-31 

干预措施:

Interventions:

组别:

Group1-1

样本量:

20

Group:

Group1-1

Sample size:

干预措施:

No

干预措施代码:

Intervention:

No

Intervention code:

组别:

Group1-2-1

样本量:

10

Group:

Group1-2-1

Sample size:

干预措施:

四联疗法+益生菌

干预措施代码:

Intervention:

quadruple therapy combined with probiotics

Intervention code:

组别:

Group1-2-2

样本量:

10

Group:

Group1-2-2

Sample size:

干预措施:

四联疗法(艾司奥美拉唑、枸橼酸铋钾、阿莫西林、克拉霉素)

干预措施代码:

Intervention:

quadruple therapy (esomeprazole, bismuth potassium citrate, amoxicillin, clarithromycin)

Intervention code:

组别:

Group1-2-3

样本量:

10

Group:

Group1-2-3

Sample size:

干预措施:

益生菌(婴儿双歧杆菌、嗜酸乳杆菌、粪肠球菌、蜡样芽胞杆菌)

干预措施代码:

Intervention:

Probiotics (Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live)

Intervention code:

组别:

Group2-1

样本量:

20

Group:

Group2-1

Sample size:

干预措施:

No

干预措施代码:

Intervention:

No

Intervention code:

组别:

Group2-2-1

样本量:

20

Group:

Group2-2-1

Sample size:

干预措施:

四联疗法+益生菌

干预措施代码:

Intervention:

quadruple therapy combined with probiotics

Intervention code:

组别:

Group2-2-2

样本量:

20

Group:

Group2-2-2

Sample size:

干预措施:

四联疗法(艾司奥美拉唑、枸橼酸铋钾、阿莫西林、克拉霉素)

干预措施代码:

Intervention:

quadruple therapy (esomeprazole, bismuth potassium citrate, amoxicillin, clarithromycin)

Intervention code:

组别:

Group2-2-3

样本量:

20

Group:

Group2-2-3

Sample size:

干预措施:

益生菌(婴儿双歧杆菌、嗜酸乳杆菌、粪肠球菌、蜡样芽胞杆菌)

干预措施代码:

Intervention:

Probiotics (Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live)

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):

北京大学第三医院消化科 

单位级别:

三甲医院 

Institution
hospital:

Department of Gastroenterology, Peking University Third Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

胃菌群结构变化

指标类型:

主要指标 

Outcome:

gastric microbiota structure

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

粪便菌群结构变化

指标类型:

主要指标 

Outcome:

fecal microbiota structure

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清胃功能指标

指标类型:

次要指标 

Outcome:

Gastric function indicator

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

HP根除率

指标类型:

次要指标 

Outcome:

HP elimination rate

Type:

Secondary 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:

胃粘膜活检标本

组织:

Sample Name:

Gastric mucosa biopsy sample

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:

胃液

组织:

Sample Name:

Gastric juice

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:

标本中文名:

血清

组织:

Sample Name:

serum

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 30 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):

由计算机产生随机表

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

A randomization scheme generated by computer

盲法:

未说明

Blinding:

Not stated

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):

北京大学第三医院消化科

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

Department of Gastroenterology,Peking University Third Hospital

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:

CRF

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-08-02
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