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

NCT ID: NCT06399562

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1516 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-20
• Study Completion Date: 2024-04-30

Brief 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.

Conditions

Helicobacter Pylori Infection

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

the physical examination population

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

carbon-13 urea breath test (13C-UBT)

Intervention Type: 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

Intervention Type: 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.

the community residents

the family-based community residents in Changsha

carbon-13 urea breath test (13C-UBT)

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

questionnaires

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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;

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second People's Hospital of Huaihua

UNKNOWN

Sponsor Role: collaborator

Yueyang Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role: collaborator

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Fen Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Changsha, Hunan, China

Countries

China

Other Identifiers

FastI 22136

Identifier Type: -

Identifier Source: org_study_id