Clinical trial NCT05654857: The Prevalence of Family-unit Helicobacter Pylori Infection in Jiangsu
Official title: The Prevalence of Family-unit Helicobacter Pylori Infection in Jiangsu Based on Non-invasive PCR in Stool
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Helicobacter Pylori Infection
Keywords: Resistance Mutation
Fecal Drug Resistance Gene Detection
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 4000
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Prevalence of Family-unit Helicobacter Pylori Infection in Jiangsu
timeFrame: 2022.12.1-2023.6.30
Secondary outcomes:
measure: Trends of Antimicrobial Resistance of Helicobacter Pylori in Jiangsu
timeFrame: 2022.12.1-2023.6.30
Other outcomes:
Locations:
city: Changzhou
country: China
facility: Changzhou Traditional Chinese medical hospital,Affiliated to Nanjing University of Chinese Medicine
state: Jiangsu
city: Huaian
country: China
facility: JinHu county people's hospital
state: Jiangsu
city: Lianyungang
country: China
facility: The 1st people's hospital of Lianyungang
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital, Nanjing Medical University
state: Jiangsu
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Nantong
country: China
facility: Rudong County People's Hospital
state: Jiangsu
city: Suqian
country: China
facility: The Affiliated Shuyang Hospital of Xuzhou Medical University
state: Jiangsu
city: Suzhou
country: China
facility: Changshu No.1 People's Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Department of Gastroenterology Wuxi People's Hospital Affiliated to Nanjing Medical University
state: Jiangsu
city: Xuzhou
country: China
facility: The First People's Hospital of Xuzhou, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University
state: Jiangsu
city: Yancheng
country: China
facility: Dongtai People's Hospital
state: Jiangsu
city: Yancheng
country: China
facility: Yancheng First Hospital Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Yangzhou
country: China
facility: Affiliated Hospital of Yangzhou University
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Suzhou
country: China
facility: Changshu Hospital Affiliated to Nanjing University of Chinese Medicine
city: Zhenjiang
country: China
facility: People's hospital of Yangzhong City
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Zhenyu Zhang
role: STUDY_CHAIR
References: