Helicobacter Pylori InfectionNCT05654857
The Prevalence of Family-unit Helicobacter Pylori Infection in Jiangsu
An observational study of Helicobacter Pylori Infection, run by Nanjing First Hospital, Nanjing Medical University at 16 sites in China.
Trial summary
To assess Family-unit Helicobacter Pylori Infection rates and antimicrobial resistance rates in Jiangsu,China Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- PCR test in the stool
- How many people
- 4,000 participants
- Where
- 16 sitesChina
- Study dates
- 1 Mar 2023to 30 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study was a sample survey of the community population in each central lock-in area, rather than hospital patients.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites, 16 recruiting
- Not yet recruiting
Changzhou Traditional Chinese medical hospital,Affiliated to Nanjing University of Chinese Medicine
Changzhou, Jiangsu
Xiaofeng Ye, +86 13915066716, y13915066716@126.com
Xiaofeng Ye
- Recruiting
JinHu county people's hospital
Huaian, Jiangsu
Jun Wang, +86 18915198177, jhwangjun@126.com
Jun Wang
- Recruiting
The 1st people's hospital of Lianyungang
Lianyungang, Jiangsu
Shengxiang Lv, +86 18961320781, lvshengxiang2009@126.com
Shengxiang Lv
- Recruiting
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210000
Zhenyu Zhang, +86 025-87726248, zzy6565@sina.com
Zhenyu Zhang
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu
Cuihua Lu, +86 13962801685, lch670608@sina.com
Cuihua Lu
- Recruiting
Rudong County People's Hospital
Nantong, Jiangsu
Weibing Xu, +86 13773799779, xwbsy@sina.cn
Weibing Xu
- Recruiting
The Affiliated Shuyang Hospital of Xuzhou Medical University
Suqian, Jiangsu
Zhengyuan Xu, +86 13951245858, 2232469762@qq.com
Zhengyuan Xu
- Recruiting
Changshu No.1 People's Hospital
Suzhou, Jiangsu
Xiaodan Xu, +86 18913631835, xxd20@163.com
Xiaodan Xu
- Not yet recruiting
Changshu Hospital Affiliated to Nanjing University of Chinese Medicine
Suzhou
Meijuan Xi, +8613862318196, ximj333@126.com
Jian Tao, +86 15995927193
- Recruiting
Department of Gastroenterology Wuxi People's Hospital Affiliated to Nanjing Medical University
Wuxi, Jiangsu
Qiang Zhan, +86 133 5811 1976, zhanq33@163.com
Qiang Zhan
- Recruiting
The First People's Hospital of Xuzhou, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University
Xuzhou, Jiangsu
Guangxia Chen, +86 136 8513 5997, gx_chen2010@163.com
Guangxia Chen
- Not yet recruiting
Dongtai People's Hospital
Yancheng, Jiangsu
Jianhua Cui, +86 13905111556, dtrmyycjh@163.com
Jianhua Cui
- Not yet recruiting
Yancheng First Hospital Affiliated Hospital of Nanjing University Medical School
Yancheng, Jiangsu
Xundong Wu, +86 15861974719, lixiangsu39@126.com
Xundong Wu
- Recruiting
Affiliated Hospital of Yangzhou University
Yangzhou, Jiangsu
Yanbing Ding, ybding@yzu.edu.cn
Yanbing Ding
- Not yet recruiting
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu
Min Xu, +86 15862990603, Peterxu1974@163.com
Min Xu
- Not yet recruiting
People's hospital of Yangzhong City
Zhenjiang
Guiping Cui, +86 18912118055, yzcgp314007@sina.com
Bing Shi, +86 18912118048
About this study
Official title: The Prevalence of Family-unit Helicobacter Pylori Infection in Jiangsu Based on Non-invasive PCR in Stool
To assess Family-unit Helicobacter Pylori Infection rates and antimicrobial resistance rates in Jiangsu,China
Read the 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.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- PCR test in the stool
- Keywords
- Resistance Mutation, Fecal Drug Resistance Gene Detection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
The Prevalence of Family-unit Helicobacter Pylori Infection in Jiangsu
the Helicobacter Pylori Infection rate in Jiangsu family
Measured: 2022.12.1-2023.6.30
Secondary outcomes (1)
Trends of Antimicrobial Resistance of Helicobacter Pylori in Jiangsu
resistance to antimicrobial agents applicable for H. pylori eradication
Measured: 2022.12.1-2023.6.30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start1 Mar 2023
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenyu Zhang, Nanjing First Hospital, Nanjing Medical University
- Investigators
- Zhenyu Zhang, Study chair, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654857
- Sponsor's protocol ID
- KY20221124-09
- Status last verified
- Aug 2023
- First submitted
- 8 Dec 2022
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Family-unit Helicobacter Pylori Infection in Jiangsu Based on Non-invasive PCR in Stool
- ClinicalTrials.gov ID
- NCT05654857
- Acronym / sponsor ID
- KY20221124-09
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Resistance Mutation, Fecal Drug Resistance Gene Detection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study was a sample survey of the community population in each central lock-in area, rather than hospital patients.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCR test in the stoolPatients 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. | Diagnostic test | – |
Primary outcome
The Prevalence of Family-unit Helicobacter Pylori Infection in Jiangsu
Time frame: 2022.12.1-2023.6.30
the Helicobacter Pylori Infection rate in Jiangsu family
1 secondary outcome
Trends of Antimicrobial Resistance of Helicobacter Pylori in Jiangsu
Time frame: 2022.12.1-2023.6.30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenyu Zhang study chair
Nanjing First Hospital, Nanjing Medical University
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection, run by Nanjing First Hospital, Nanjing Medical University at 16 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenyu Zhang (+86 025-87726248, zzy6565@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Prevalence of Family-unit Helicobacter Pylori Infection in Jiangsu (time frame: 2022.12.1-2023.6.30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.