The Prevalence of Family-unit Helicobacter Pylori Infection in Jiangsu

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05654857
• Other study ID #: KY20221124-09
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: August 30, 2023

Study information

• Verified date: August 2023
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Zhenyu Zhang
• Phone: +86 025-87726248
• Email: zzy6565[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
China	Changzhou Traditional Chinese medical hospital,Affiliated to Nanjing University of Chinese Medicine	Changzhou	Jiangsu
China	JinHu county people's hospital	Huaian	Jiangsu
China	The 1st people's hospital of Lianyungang	Lianyungang	Jiangsu
China	Nanjing First Hospital, Nanjing Medical University	Nanjing	Jiangsu
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu
China	Rudong County People's Hospital	Nantong	Jiangsu
China	The Affiliated Shuyang Hospital of Xuzhou Medical University	Suqian	Jiangsu
China	Changshu Hospital Affiliated to Nanjing University of Chinese Medicine	Suzhou
China	Changshu No.1 People's Hospital	Suzhou	Jiangsu
China	Department of Gastroenterology Wuxi People's Hospital Affiliated to Nanjing Medical University	Wuxi	Jiangsu
China	The First People's Hospital of Xuzhou, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University	Xuzhou	Jiangsu
China	Dongtai People's Hospital	Yancheng	Jiangsu
China	Yancheng First Hospital Affiliated Hospital of Nanjing University Medical School	Yancheng	Jiangsu
China	Affiliated Hospital of Yangzhou University	Yangzhou	Jiangsu
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu
China	People's hospital of Yangzhong City	Zhenjiang

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Prevalence of Family-unit Helicobacter Pylori Infection in Jiangsu	the Helicobacter Pylori Infection rate in Jiangsu family	2022.12.1-2023.6.30
Secondary	Trends of Antimicrobial Resistance of Helicobacter Pylori in Jiangsu	resistance to antimicrobial agents applicable for H. pylori eradication	2022.12.1-2023.6.30