The Prevalence of Family-unit Helicobacter Pylori Infection in Jiangsu

August 14, 2023 updated by: Zhenyu Zhang, Nanjing First Hospital, Nanjing Medical University

The Prevalence of Family-unit Helicobacter Pylori Infection in Jiangsu Based on Non-invasive PCR in Stool

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Suzhou, China
        • Not yet recruiting
        • Changshu Hospital Affiliated to Nanjing University of Chinese Medicine
        • Contact:
        • Contact:
          • Jian Tao
          • Phone Number: +86 15995927193
      • Zhenjiang, China
        • Not yet recruiting
        • People's hospital of Yangzhong City
        • Contact:
        • Contact:
          • Bing Shi
          • Phone Number: +86 18912118048
    • Jiangsu
      • Changzhou, Jiangsu, China
        • Not yet recruiting
        • Changzhou Traditional Chinese medical hospital,Affiliated to Nanjing University of Chinese Medicine
        • Principal Investigator:
          • Xiaofeng Ye
        • Sub-Investigator:
          • Lu Shen
        • Contact:
      • Huaian, Jiangsu, China
        • Recruiting
        • JinHu county people's hospital
        • Principal Investigator:
          • Jun Wang
        • Contact:
        • Sub-Investigator:
          • Rong Ou
      • Lianyungang, Jiangsu, China
        • Recruiting
        • The 1st people's hospital of Lianyungang
        • Contact:
        • Principal Investigator:
          • Shengxiang Lv
        • Sub-Investigator:
          • Zhimei Zhang, Zhang
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Nanjing First Hospital, Nanjing Medical University
        • Contact:
        • Principal Investigator:
          • Zhenyu Zhang
        • Principal Investigator:
          • Bangshun He
        • Sub-Investigator:
          • Yunfan Dong
        • Sub-Investigator:
          • Wenjuan Wei
      • Nantong, Jiangsu, China
        • Recruiting
        • Affiliated Hospital of Nantong University
        • Contact:
        • Principal Investigator:
          • Cuihua Lu
        • Sub-Investigator:
          • Hao Chen
      • Nantong, Jiangsu, China
        • Recruiting
        • Rudong County People's Hospital
        • Contact:
        • Principal Investigator:
          • Weibing Xu
        • Sub-Investigator:
          • Jiawen Hong
      • Suqian, Jiangsu, China
        • Recruiting
        • The Affiliated Shuyang Hospital of Xuzhou Medical University
        • Contact:
        • Principal Investigator:
          • Zhengyuan Xu
        • Sub-Investigator:
          • Jiabing Wang
      • Suzhou, Jiangsu, China
        • Recruiting
        • Changshu No.1 People's Hospital
        • Principal Investigator:
          • Xiaodan Xu
        • Contact:
        • Sub-Investigator:
          • Ruifang Wang
      • Wuxi, Jiangsu, China
        • Recruiting
        • Department of Gastroenterology Wuxi People's Hospital Affiliated to Nanjing Medical University
        • Principal Investigator:
          • Qiang Zhan
        • Contact:
        • Sub-Investigator:
          • Lixia Ding
        • Sub-Investigator:
          • Mindan Huang
      • Xuzhou, Jiangsu, China
        • Recruiting
        • The First People's Hospital of Xuzhou, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University
        • Principal Investigator:
          • Guangxia Chen
        • Sub-Investigator:
          • Xinxin Xu
        • Sub-Investigator:
          • Min Liu
        • Contact:
      • Yancheng, Jiangsu, China
        • Not yet recruiting
        • Dongtai People'S Hospital
        • Contact:
        • Principal Investigator:
          • Jianhua Cui
        • Sub-Investigator:
          • Lin Chen
        • Sub-Investigator:
          • Chong Chen
      • Yancheng, Jiangsu, China
        • Not yet recruiting
        • Yancheng First Hospital Affiliated Hospital of Nanjing University Medical School
        • Contact:
        • Principal Investigator:
          • Xundong Wu
        • Sub-Investigator:
          • Xiangsu Li
      • Yangzhou, Jiangsu, China
        • Recruiting
        • Affiliated Hospital of Yangzhou University
        • Principal Investigator:
          • Yanbing Ding
        • Sub-Investigator:
          • Zhaotao Duan
        • Contact:
      • Zhenjiang, Jiangsu, China
        • Not yet recruiting
        • Affiliated Hospital of Jiangsu University
        • Principal Investigator:
          • Min Xu
        • Contact:
        • Sub-Investigator:
          • Lamei Xu
        • Sub-Investigator:
          • Han Jiang
        • Sub-Investigator:
          • Sihui Wu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The study was a sample survey of the community population in each central lock-in area, rather than hospital patients.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Prevalence of Family-unit Helicobacter Pylori Infection in Jiangsu
Time Frame: 2022.12.1-2023.6.30
the Helicobacter Pylori Infection rate in Jiangsu family
2022.12.1-2023.6.30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trends of Antimicrobial Resistance of Helicobacter Pylori in Jiangsu
Time Frame: 2022.12.1-2023.6.30
resistance to antimicrobial agents applicable for H. pylori eradication
2022.12.1-2023.6.30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Investigators

  • Study Chair: Zhenyu Zhang, Nanjing First Hospital, Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

August 30, 2023

Study Completion (Estimated)

August 30, 2023

Study Registration Dates

First Submitted

December 8, 2022

First Submitted That Met QC Criteria

December 8, 2022

First Posted (Actual)

December 16, 2022

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20221124-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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