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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanjing First Hospital, Nanjing Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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