NCT05654857

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

16 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

December 8, 2022

Last Update Submit

August 14, 2023

Conditions

Keywords

Resistance MutationFecal Drug Resistance Gene Detection

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Trends of Antimicrobial Resistance of Helicobacter Pylori in Jiangsu

    2022.12.1-2023.6.30

Interventions

PCR test in the stoolDIAGNOSTIC_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.

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Changzhou Traditional Chinese medical hospital,Affiliated to Nanjing University of Chinese Medicine

Changzhou, Jiangsu, China

NOT YET RECRUITING

JinHu county people's hospital

Huaian, Jiangsu, China

RECRUITING

The 1st people's hospital of Lianyungang

Lianyungang, Jiangsu, China

RECRUITING

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

RECRUITING

Rudong County People's Hospital

Nantong, Jiangsu, China

RECRUITING

The Affiliated Shuyang Hospital of Xuzhou Medical University

Suqian, Jiangsu, China

RECRUITING

Changshu No.1 People's Hospital

Suzhou, Jiangsu, China

RECRUITING

Department of Gastroenterology Wuxi People's Hospital Affiliated to Nanjing Medical University

Wuxi, Jiangsu, China

RECRUITING

The First People's Hospital of Xuzhou, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University

Xuzhou, Jiangsu, China

RECRUITING

Dongtai People's Hospital

Yancheng, Jiangsu, China

NOT YET RECRUITING

Yancheng First Hospital Affiliated Hospital of Nanjing University Medical School

Yancheng, Jiangsu, China

NOT YET RECRUITING

Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

RECRUITING

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

NOT YET RECRUITING

Changshu Hospital Affiliated to Nanjing University of Chinese Medicine

Suzhou, China

NOT YET RECRUITING

People's hospital of Yangzhong City

Zhenjiang, China

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

stool specimen produced by normal excretion

Study Officials

  • Zhenyu Zhang

    Nanjing First Hospital, Nanjing Medical University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Gastroenterology

Study Record Dates

First Submitted

December 8, 2022

First Posted

December 16, 2022

Study Start

March 1, 2023

Primary Completion

August 30, 2023

Study Completion

August 30, 2023

Last Updated

August 16, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations