ChiCTR2400084367 版本V1.1 版本创建时间2025/09/02 15:53:08 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2400084367 

最近更新日期：

Date of Last Refreshed on：

2024-05-15 11:55:41 

注册时间：

Date of Registration：

2024-05-15 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于粪便PCR检测的家庭幽门螺杆菌精准治疗

Public title：

Precision treatment of Helicobacter pylori in households based on fecal PCR detection

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于粪便PCR检测的家庭幽门螺杆菌精准治疗

Scientific title：

Precision treatment of Helicobacter pylori in households based on fecal PCR detection

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：

冯璜 

研究负责人：

冯璜 

Applicant：

Feng Huang 

Study leader：

Feng Huang 

申请注册联系人电话：

Applicant telephone：

+86 158 5016 5709

研究负责人电话：

Study leader's telephone：

+86 158 5016 5709

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：

nancyfh@163.com

研究负责人电子邮件：

Study leader's E-mail：

nancyfh@163.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：

江苏省苏州市姑苏区平海路899号苏大附一院总院

研究负责人通讯地址：

江苏省苏州市姑苏区平海路899号苏大附一院总院

Applicant address：

Suzhou University Affiliated First Hospital, No. 899 Pinghai Road, Gusu District, Suzhou City, Jiangsu Province

Study leader's address：

Suzhou University Affiliated First Hospital, No. 899 Pinghai Road, Gusu District, Suzhou City, Jiangsu Province

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：

苏州大学附属第一医院

Applicant's institution：

The First Affiliated Hospital of Suzhou University

研究负责人所在单位：

苏州大学附属第一医院

Affiliation of the Leader：

The First Affiliated Hospital of Suzhou University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

(2024)伦审批第127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：

苏州大学附属第一医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the First Affiliated Hospital of Suzhou University

伦理委员会批准日期：

Date of approved by ethic committee：

2024-04-17 00:00:00

伦理委员会联系人：

陈罡

Contact Name of the ethic committee：

Chen Gang

伦理委员会联系地址：

江苏省苏州市姑苏区平海路899号苏大附一院总院综合楼1312办公室

Contact Address of the ethic committee：

1312 Office, Comprehensive Building, Suzhou University Affiliated First Hospital, No. 899 Pinghai Road, Gusu District, Suzhou City, Jiangsu Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 512 6797 2861

伦理委员会联系人邮箱：

Contact email of the ethic committee：

sdfyec@163.com

研究实施负责（组长）单位：

苏州大学附属第一医院

Primary sponsor：

The First Affiliated Hospital of Suzhou University

研究实施负责（组长）单位地址：

江苏省苏州市姑苏区平海路899号苏大附一院总院

Primary sponsor's address：

Suzhou University Affiliated First Hospital, No. 899 Pinghai Road, Gusu District, Suzhou City, Jiangsu Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏省

市(区县)：

苏州

Country：

China

Province：

Jiangsu Province

City：

Suzhou

单位(医院)：

苏州大学附属第一医院

具体地址：

江苏省苏州市姑苏区平海路899号苏大附一院总院

Institution
hospital：

The First Affiliated Hospital of Suzhou University

Address：

Suzhou University Affiliated First Hospital, No. 899 Pinghai Road, Gusu District, Suzhou City, Jiangsu Province

经费或物资来源：

幽门螺杆菌粪便检测费用由康为医学检验实验室（泰州）有限公司支付，治疗方案所用药物及呼气试验所需费用由患者自己或患者个人医保承担。

Source(s) of funding：

The cost of Helicobacter pylori fecal testing will be paid by Kangwei Medical Laboratory (Taizhou) Co., Ltd. The drugs used in the treatment plan and the cost of breath tests will be borne by the patient themselves or their personal medical insurance.

Target disease：

helicobacter pylori infection

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 诊断试验新技术临床试验 

Study phase：

Diagnostic New Technique Clincal Study

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

1.横断面观察家庭内Hp感染分布情况及耐药率； 2.探讨以家庭为单位的Hp精准治疗是否可以提高根除率并具有更好的经济效益比。  

Objectives of Study：

1. Cross sectional observation of the distribution of Hp infection and drug resistance rate within households; 2. Explore whether household based precise treatment of Hp can improve eradication rates and have better economic benefits.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

(1)Hp检测阶段的研究:年龄18周岁以上(含18周岁),男女不限;确诊幽门螺杆菌感染;粪便检测前4周内未使用抗生素,2周内未使用过质子泵抑制剂(PPI)、钾离子竞争性抑制剂(P-CAB)或H2-受体拮抗剂(H2-RA);无严重便秘或肠梗阻,能留取粪便;(2)Hp治疗阶段的研究:年龄14周岁以上(含14周岁),男女不限;以下任何方式证实的Hp现症感染:13C或者14C尿素呼气试验(13C-UBT或14C-UBT)结果为阳性;粪便PCR显示Hp核酸阳性;同意服药期间禁止饮酒;同意服药期间以及服药结束后至少3个月无妊娠计划且自愿采取有效的避孕措施;无以下预警症状/体征者:不明原因的贫血、黑便/呕血、厌食、黄疸、体重减轻等;无严重的肝肾功能不全,包括:ALT及AST升高至正常上限的2倍以上;肌酐高于1.5倍正常上限;无酗酒或前5年内无酗酒史(平均每周饮用 ≥ 14个单位的酒精:1单位 = 啤酒285?mL,或烈酒25 mL,或葡萄酒100 mL);无吞咽困难或幽门梗阻;无贫血、白细胞计数或中性粒细胞计数异常、转氨酶异常等;男女性不处于备孕期,女性不处于孕期及哺乳期;心电图有无异常或心电图异常无临床意义,非过敏体质(对阿莫西林、克拉霉素、枸橼酸铋钾等不过敏);

Inclusion criteria

(1) Research on Hp detection stage: Age 18 and above (including 18 years old), regardless of gender; Confirmed Helicobacter pylori infection; No antibiotics were used within 4 weeks prior to fecal testing, and no proton pump inhibitors (PPIs), potassium competitive inhibitors (P-CABs), or H2 receptor antagonists (H2-RAs) were used within 2 weeks; No severe constipation or intestinal obstruction, able to collect feces; (2) Research on the treatment stage of Hp: Age 14 and above (including 14 years old), regardless of gender; Any of the following methods confirm the presence of Hp infection: 13C or 14C urea breath test (13C-UBT or 14C-UBT) results are positive; Fecal PCR showed positive Hp nucleic acid; Agree to prohibit alcohol consumption during medication; Agree to voluntarily take effective contraceptive measures during the medication period and for at least 3 months after the medication ends, without a pregnancy plan; Individuals without the following warning symptoms/signs: unexplained anemia, black stools/vomiting blood, anorexia, jaundice, weight loss, etc; No severe liver and kidney dysfunction, including elevated ALT and AST to more than twice the normal upper limit; Creatinine is higher than 1.5 times the normal upper limit; No history of alcoholism or alcohol abuse within the first 5 years (average weekly consumption of ≥ 14 units of alcohol: 1 unit=285 mL of beer, or 25 mL of spirits, or 100 mL of wine); No swallowing difficulties or pyloric obstruction; No anemia, abnormal white blood cell count or neutrophil count, abnormal transaminase, etc; Men and women are not in the preparation period for pregnancy, and women are not in the pregnancy and lactation period; Is there any abnormality in the electrocardiogram or is the electrocardiogram abnormal with no clinical significance, and is not allergic to amoxicillin, clarithromycin, bismuth potassium citrate, etc;

排除标准：

严重便秘或肠梗阻,无法留取粪便者;有以下预警症状/体征者:不明原因的贫血、黑便/呕血、厌食、黄疸、体重减轻等;严重的肝肾功能不全,包括:ALT及AST升高至正常上限的2倍以上;肌酐高于1.5倍正常上限;酗酒或筛选前5年内有酗酒史(平均每周饮用 ≥ 14个单位的酒精:1单位 = 啤酒285?mL,或烈酒25 mL,或葡萄酒100 mL);有吞咽困难或幽门梗阻;心电图异常有临床意义;对多种药物过敏者;白细胞计数或中性粒细胞计数低于正常值下限;男女性备孕期,女性孕期及哺乳期; 对多种药物过敏等研究者认为不适合入组的情况。

Exclusion criteria：

Severe constipation or intestinal obstruction, unable to collect feces; Individuals with the following warning symptoms/signs: unexplained anemia, black stools/vomiting blood, anorexia, jaundice, weight loss, etc; Severe liver and kidney dysfunction, including elevated ALT and AST to more than twice the normal upper limit; Creatinine is higher than 1.5 times the normal upper limit; Excessive drinking or a history of alcohol abuse within the past 5 years prior to screening (average weekly consumption of ≥ 14 units of alcohol: 1 unit=285 mL of beer, or 25 mL of spirits, or 100 mL of wine); Difficulty swallowing or pyloric obstruction; Abnormal electrocardiogram has clinical significance; Individuals who are allergic to multiple drugs; White blood cell count or neutrophil count below the lower limit of normal values; Male and female pregnancy preparation period, female pregnancy and lactation period; Researchers believe that it is not suitable to be included in the study due to allergies to multiple drugs.

研究实施时间：

Study execute time：

从 From 2024-03-01 00:00:00至 To 2026-04-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-05-15 00:00:00 至 To 2026-04-01 00:00:00  

干预措施：

Interventions：

组别：

干预组

样本量：

590

Group：

intervention group

Sample size：

干预措施：

1）收集调查问卷：发放家庭Hp相关情况调查情况。 2）粪便Hp检测：收集家庭各个成员的粪便标本，物流运输到中心实验室，进行PCR检测，评估家庭内Hp感染情况及耐药基因情况（见操作规范图）； 3）对于Hp阳性患者，结合耐药相关基因检测及宿主基因型结果，制定个体化治疗精准治疗方案

干预措施代码：

Intervention：

1) Collect survey questionnaires: Distribute household Hp related survey results. 2) Fecal Hp detection: Collect fecal samples from various family members, transport them to the central laboratory for PCR testing, evaluate the Hp infection and drug resistance genes in the family (see operating standard diagram); 3) For Hp positive patients, personalized and precise treatment plans will be developed based on drug resistance related gene testing and host genotype results

Intervention code：

组别：

对照组

样本量：

590

Group：

control group

Sample size：

干预措施：

使用经验性Hp根除方案

干预措施代码：

Intervention：

Use empirical treatment regimens for HP

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏 

市(区县)：

  

Country：

China 

Province：

Jiangsu 

City：

 

单位(医院)：

苏州大学附属第一医院 

单位级别：

三甲 

Institution
hospital：

The First Affiliated Hospital of Suzhou University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

复查Hp检测结果

指标类型：

主要指标

Outcome：

the result of the Hp test

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：

feces

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 岁 years
最大 Max age 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）：

无

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

无

Blinding：

None

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）：

无

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

None

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：

设立严格的数据管理和保护流程，采用加密和备份措施确保数据安全，只有授权人员可以访问敏感数据。

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

Establish strict data management and protection processes, use encryption and backup measures to ensure data security, and only authorized personnel can access sensitive data.

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：

  2024-05-15 11:55:17