Helicobacter Pylori InfectionNCT06399562
Related Factors of Hp Infection in Physical Examination and Community Population in Hunan Province
An observational study of Helicobacter Pylori Infection, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This study intends to investigate the prevalence and risk factors of Helicobacter pylori (H. pylori) infection in the population of physical examination centers and communities. The physical examination population from the health management center of the Third Xiangya Hospital and the family-based community residents… Read more about this study
- Who is it for?
- Ages 4 to 90 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- carbon-13 urea breath test (13C-UBT) and questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,516 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2024to 30 Apr 2024
- 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 4 to 90 years
- All sexes
- Child, Adult, Older adult
Study population: 1. the physical examination population from all over the country was randomly selected from the Health Management Center of the Third Xiangya Hospital; 2. the family-based community residents were randomly selected in Changsha. [families containing two or more family members (living together for more than 10 consecutive months per year) and the family members aged 3 years and above];
Who may be able to join
- population aged 4-90 years, no requirement for gender;
- the physical examination population from the health management center of the Third Xiangya Hospital;
- the family-based community residents in Changsha City [families containing two or more family members (living together for more than 10 consecutive months per year) and the family members aged 3 years and above];
Who cannot join
- people with use of antibiotics, bismuth or Chinese traditional medicines with antibacterial effects in the previous 4 weeks of 13C-UBT, or H2 receptor antagonists, PPIs, P-CAB or other drugs affecting H. pylori activity within the previous 2 weeks of 13C-UBT;
- people with H. pylori treatment within the past 3 months;
- People who fasted less than 3 hours before 13C-UBT;
- people with other contraindications to performing 13C-UBT;
- people living alone in a family;
- people with incomplete questionnaire information;
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- people with serious diseases or clinical conditions that may interfere with the evaluation of the results of the study, such as severe heart, liver, lung, and renal insufficiency, low immunity, and so on;
- people with mental illness and communication disorders;
- people deemed unsuitable by the researchers to participate in this project;
Trial locations and contacts
1 site in 1 country.
China1 site
outpatient department of gastroenterology of the Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
About this study
Official title: Related Factors of Hp Infection in Physical Examination and Community Population in Hunan Province: A Cross-sectional Study
This study intends to investigate the prevalence and risk factors of Helicobacter pylori (H. pylori) infection in the population of physical examination centers and communities. The physical examination population from the health management center of the Third Xiangya Hospital and the family-based community residents in Changsha were randomly selected. The H. pylori infection was detected by carbon-13 urea breath test (13C-UBT), and the related factors of H. pylori infection were investigated by questionnaire survey. The study provides supporting evidences to implement family-base H. pylori management to curb its intrafamilial spread. The results have important clinical implications in refinement of eradication strategies and impact on public health policy formulation for related disease prevention.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- carbon-13 urea breath test (13C-UBT), questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbon-13 urea breath test (13C-UBT)Diagnostic test
The H. pylori infection was detected by carbon-13 urea breath test (13C-UBT), a delta over baseline (DOB) of ≥4.0 was considered positive for H. pylori, and a DOB<4.0 was considered negative.
questionnairesBehavioural
The related factors of H. pylori infection were investigated by questionnaire survey. The physical examination population participated in the questionnaires of the physical examination center, which included basic demographic characteristics and living habits, and filled out the questionnaires on the use of serving chopsticks at the same time. In the community, members of each eligible family were asked to complete a questionnaire including the details such family general information, basic information of every family member, personal living habits, past medical history, and so on.
| Study group | Role | What they receive |
|---|---|---|
| the physical examination population | the physical examination population from the health management center of the Third Xiangya Hospital Receives: Diagnostic Test: carbon-13 urea breath test (13C-UBT); Behavioral: questionnaires | |
| the community residents | the family-based community residents in Changsha Receives: Diagnostic Test: carbon-13 urea breath test (13C-UBT); Behavioral: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori eradication rate
carbon-13 urea breath test
Measured: through study completion, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start20 Apr 2024
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
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 The Third Xiangya Hospital of Central South 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,516 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Second People's Hospital of Huaihua, Yueyang Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Fen Wang, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399562
- Sponsor's protocol ID
- FastI 22136
- Status last verified
- Jun 2024
- First submitted
- 20 Apr 2024
- Last updated
- 3 Jul 2024
- Results posted
- 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Related Factors of Hp Infection in Physical Examination and Community Population in Hunan Province: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06399562
- Acronym / sponsor ID
- FastI 22136
- Conditions
- Helicobacter Pylori Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,516 participants (actual)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- The Second People's Hospital of Huaihua, Yueyang Hospital of Traditional Chinese Medicine
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 3 May 2024 (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.
This study intends to investigate the prevalence and risk factors of Helicobacter pylori (H. pylori) infection in the population of physical examination centers and communities. The physical examination population from the health management center of the Third Xiangya Hospital and the family-based community residents in Changsha were randomly selected. The H. pylori infection was detected by carbon-13 urea breath test (13C-UBT), and the related factors of H. pylori infection were investigated by questionnaire survey. The study provides supporting evidences to implement family-base H. pylori management to curb its intrafamilial spread. The results have important clinical implications in refinement of eradication strategies and impact on public health policy formulation for related disease prevention.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the physical examination population | – | Diagnostic Test: carbon-13 urea breath test (13C-UBT), Behavioral: questionnairesthe physical examination population from the health management center of the Third Xiangya Hospital |
| the community residents | – | Diagnostic Test: carbon-13 urea breath test (13C-UBT), Behavioral: questionnairesthe family-based community residents in Changsha |
Who may qualify
- Ages
- 4 to 90 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 1. the physical examination population from all over the country was randomly selected from the Health Management Center of the Third Xiangya Hospital; 2. the family-based community residents were randomly selected in Changsha. [families containing two or more family members (living together for more than 10 consecutive months per year) and the family members aged 3 years and above];
Key inclusion criteria (3 listed)
- population aged 4-90 years, no requirement for gender;
- the physical examination population from the health management center of the Third Xiangya Hospital;
- the family-based community residents in Changsha City [families containing two or more family members (living together for more than 10 consecutive months per year) and the family members aged 3 years and above];
Key exclusion criteria (9 listed)
- people with use of antibiotics, bismuth or Chinese traditional medicines with antibacterial effects in the previous 4 weeks of 13C-UBT, or H2 receptor antagonists, PPIs, P-CAB or other drugs affecting H. pylori activity within the previous 2 weeks of 13C-UBT;
- people with H. pylori treatment within the past 3 months;
- People who fasted less than 3 hours before 13C-UBT;
- people with other contraindications to performing 13C-UBT;
- people living alone in a family;
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 |
|---|---|---|
| carbon-13 urea breath test (13C-UBT)The H. pylori infection was detected by carbon-13 urea breath test (13C-UBT), a delta over baseline (DOB) of ≥4.0 was considered positive for H. pylori, and a DOB<4.0 was considered negative. | Diagnostic test | the community residents, the physical examination population |
| questionnairesThe related factors of H. pylori infection were investigated by questionnaire survey. The physical examination population participated in the questionnaires of the physical examination center, which included basic demographic characteristics and living habits, and filled out the questionnaires on the use of serving chopsticks at the same time. In the community, members of each eligible family were asked to complete a questionnaire including the details such family general information, basic information of every family member, personal living habits, past medical history, and so on. | Behavioural | the community residents, the physical examination population |
Primary outcome
Helicobacter pylori eradication rate
Time frame: through study completion, an average of 1 week
carbon-13 urea breath test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 The Third Xiangya Hospital of Central South University at 1 site 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helicobacter pylori eradication rate (time frame: through study completion, an average of 1 week). 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 3 Jul 2024.