The Prevalence of Family-unit Helicobacter Pylori Infecti... | NCT05654857

Studies
The Prevalence of Family-unit Helicobacter Pylori Infection in Jiangsu

NCT05654857

Sponsor

Nanjing First Hospital, Nanjing Medical University

Status

Unknown status

Last Update Posted

Aug 16, 2023Actual

Enrollment

4,000Estimated

Phase

Not provided

Conditions

Helicobacter Pylori Infection

Interventions

PCR test in the stool

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2023Actual

Primary Completion Date

Aug 30, 2023Estimated

Completion Date

Aug 30, 2023Estimated

First Submitted Date

Dec 8, 2022

First Submission Date that Met QC Criteria

Dec 8, 2022

First Posted Date

Dec 16, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2023

Last Update Posted Date

Aug 16, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhenyu Zhang, Director of Gastroenterology, Nanjing First Hospital, Nanjing Medical UniversityPrincipal Investigator

Lead Sponsor

Nanjing First Hospital, Nanjing Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

4,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PCR test in the stool	Diagnostic Test	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

community population
Fecal samples can be obtained, and the sample volume meets the requirements of the collection tube instructions
Only one person per family can be selected
Voluntarily participated in this study and signed an informed consent form

Exclusion Criteria:

The collector does not cooperate or has poor compliance;
Adequate and qualified fecal samples could not be obtained;
Stool samples were collected during diarrhea or constipation;
Antibiotics, bismuth preparations, proton pump inhibitors and other Hp sensitive drugs have been used within one month.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhenyu Zhang	Contact	+86 025-87726248		zzy6565@sina.com
Yunfan Dong	Contact	+86 18795993220		dyf967878@163.com

Overall Officials

Name	Affiliation	Role
Zhenyu Zhang	Nanjing First Hospital, Nanjing Medical University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Changzhou Traditional Chinese medical hospital,Affiliated to Nanjing University of Chinese Medicine	Not yet recruiting	Changzhou	Jiangsu		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided