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The Prevalence of Family-unit Helicobacter Pylori Infection in Jiangsu

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05654857
Enrollment
4000
Registered
2022-12-16
Start date
2023-03-01
Completion date
2023-08-30
Last updated
2023-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Keywords

Resistance Mutation, Fecal Drug Resistance Gene Detection

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.

Interventions

DIAGNOSTIC_TESTPCR 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.

Sponsors

Nanjing First Hospital, Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The Prevalence of Family-unit Helicobacter Pylori Infection in Jiangsu2022.12.1-2023.6.30the Helicobacter Pylori Infection rate in Jiangsu family

Secondary

MeasureTime frameDescription
Trends of Antimicrobial Resistance of Helicobacter Pylori in Jiangsu2022.12.1-2023.6.30resistance to antimicrobial agents applicable for H. pylori eradication

Countries

China

Contacts

Primary ContactZhenyu Zhang
zzy6565@sina.com+86 025-87726248
Backup ContactYunfan Dong
dyf967878@163.com+86 18795993220

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026