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NCT Number: NCT06399562

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

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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Key information

Age range

4 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

outpatient department of gastroenterology of the Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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];

Exclusion criteria

  • 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;
  • 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;

Treatment and study plan

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.

Questionnaires

Behavioral

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.

Primary outcomes

  1. Helicobacter pylori eradication rate

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

    carbon-13 urea breath test

Sponsors and collaborators

Lead sponsor

The Third Xiangya Hospital of Central South University

Other

Collaborators

  • The Second People's Hospital of Huaihua
  • Yueyang Hospital of Traditional Chinese Medicine

Registry information

Official study title

Related Factors of Hp Infection in Physical Examination and Community Population in Hunan Province: A Cross-sectional Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 3, 2024
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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