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CompletedNCT06399562Updated Jul 3, 2024

Related Factors of Hp Infection in Physical Examination and Community Population in Hunan Province

An observational study in Helicobacter Pylori Infection, sponsored by The Third Xiangya Hospital of Central South University. Completed at 1 site in China. Open to participants aged 4 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by The Third Xiangya Hospital of Central South University · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
1,516
Ages
4 Years to 90 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Helicobacter Pylori Infection
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In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 1,516 is above the median of 240 across 2,136 observational studies indexed under Infections.

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Lead sponsor

The Third Xiangya Hospital of Central South University is the lead sponsor of 95 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 90 Years
Sexes eligible
All
Sampling method
Non-probability sample

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];

Inclusion criteria

  1. population aged 4-90 years, no requirement for gender;
  2. the physical examination population from the health management center of the Third Xiangya Hospital;
  3. 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];

Exclusion criteria

Exclusion Criteria:

  1. 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;
  2. people with H. pylori treatment within the past 3 months;
  3. People who fasted less than 3 hours before 13C-UBT;
  4. people with other contraindications to performing 13C-UBT;
  5. people living alone in a family;
  6. people with incomplete questionnaire information;
  7. 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;
  8. people with mental illness and communication disorders;
  9. people deemed unsuitable by the researchers to participate in this project;
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Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
1,516 participants (actual)
Patient registry
No

Groups and cohorts

  • the physical examination population

    the physical examination population from the health management center of the Third Xiangya Hospital

    Diagnostic Test: carbon-13 urea breath test (13C-UBT) · Behavioral: questionnaires

  • the community residents

    the family-based community residents in Changsha

    Diagnostic Test: carbon-13 urea breath test (13C-UBT) · Behavioral: questionnaires

Interventions

  • Diagnostic testcarbon-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.

  • Behavioralquestionnaires

    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.

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What researchers measure

Primary outcomes

  1. Helicobacter pylori eradication rate

    carbon-13 urea breath test

    Time frame: through study completion, an average of 1 week

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Study locations

1 site
  • outpatient department of gastroenterology of the Third Xiangya Hospital of Central South University
    Changsha, Hunan 410013, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06399562
Lead sponsor
The Third Xiangya Hospital of Central South University
Collaborators
The Second People's Hospital of Huaihua, Yueyang Hospital of Traditional Chinese Medicine
Responsible party
Fen Wang (Professor, The Third Xiangya Hospital of Central South University) — Principal investigator
First posted
May 3, 2024
Start date
Apr 20, 2024
Primary completion
Apr 30, 2024
Completion
Apr 30, 2024
Last update
Jul 3, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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