The Prevalence of Family-unit Helicobacter Pylori Infection in Jiangsu

NCT ID: NCT05654857

Last Updated: 2023-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To assess Family-unit Helicobacter Pylori Infection rates and antimicrobial resistance rates in Jiangsu,China

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study is a sample survey of the community population in cities of Jiangsu where the centers are located.The Helicobacter pylori infection and drug-resistant gene mutations are detected by real-time PCR performed on the stools of subjects.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Helicobacter Pylori Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PCR test in the stool

Patients will receive a prescription for a stool self-collection kit . Only the result of the PCR test in the stool will be considered for this arm. A positive test will determine Hp infection and the indication for treatment.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. community population
2. Fecal samples can be obtained, and the sample volume meets the requirements of the collection tube instructions
3. Only one person per family can be selected
4. Voluntarily participated in this study and signed an informed consent form

Exclusion Criteria

1. The collector does not cooperate or has poor compliance;
2. Adequate and qualified fecal samples could not be obtained;
3. Stool samples were collected during diarrhea or constipation;
4. Antibiotics, bismuth preparations, proton pump inhibitors and other Hp sensitive drugs have been used within one month.
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhenyu Zhang

Director of Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zhenyu Zhang

Role: STUDY_CHAIR

Nanjing First Hospital, Nanjing Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Changzhou Traditional Chinese medical hospital,Affiliated to Nanjing University of Chinese Medicine

Changzhou, Jiangsu, China

Site Status NOT_YET_RECRUITING

JinHu county people's hospital

Huaian, Jiangsu, China

Site Status RECRUITING

The 1st people's hospital of Lianyungang

Lianyungang, Jiangsu, China

Site Status RECRUITING

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Site Status RECRUITING

Rudong County People's Hospital

Nantong, Jiangsu, China

Site Status RECRUITING

The Affiliated Shuyang Hospital of Xuzhou Medical University

Suqian, Jiangsu, China

Site Status RECRUITING

Changshu No.1 People's Hospital

Suzhou, Jiangsu, China

Site Status RECRUITING

Department of Gastroenterology Wuxi People's Hospital Affiliated to Nanjing Medical University

Wuxi, Jiangsu, China

Site Status RECRUITING

The First People's Hospital of Xuzhou, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status RECRUITING

Dongtai People's Hospital

Yancheng, Jiangsu, China

Site Status NOT_YET_RECRUITING

Yancheng First Hospital Affiliated Hospital of Nanjing University Medical School

Yancheng, Jiangsu, China

Site Status NOT_YET_RECRUITING

Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

Site Status RECRUITING

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Site Status NOT_YET_RECRUITING

Changshu Hospital Affiliated to Nanjing University of Chinese Medicine

Suzhou, , China

Site Status NOT_YET_RECRUITING

People's hospital of Yangzhong City

Zhenjiang, , China

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zhenyu Zhang

Role: CONTACT

+86 025-87726248

Yunfan Dong

Role: CONTACT

+86 18795993220

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Xiaofeng Ye

Role: primary

+86 13915066716

Jun Wang

Role: primary

+86 18915198177

Shengxiang Lv

Role: primary

+86 18961320781

Zhenyu Zhang

Role: primary

+86 025-87726248

Cuihua Lu

Role: primary

+86 13962801685

Weibing Xu

Role: primary

+86 13773799779

Zhengyuan Xu

Role: primary

+86 13951245858

Xiaodan Xu

Role: primary

+86 18913631835

Qiang Zhan

Role: primary

+86 133 5811 1976

Guangxia Chen

Role: primary

+86 136 8513 5997

Jianhua Cui

Role: primary

+86 13905111556

Xundong Wu

Role: primary

+86 15861974719

Yanbing Ding

Role: primary

Min Xu

Role: primary

+86 15862990603

Meijuan Xi

Role: primary

+8613862318196

Jian Tao

Role: backup

+86 15995927193

Guiping Cui

Role: primary

+86 18912118055

Bing Shi

Role: backup

+86 18912118048

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KY20221124-09

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.