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

NCT06399562 | Completed

• 1 other identifier: FastI 22136
• Study Type: observational
• Target: 1,516
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori eradication rate

  carbon-13 urea breath test

  through study completion, an average of 1 week

Study Arms (2)

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

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.

the community residents; the physical examination population

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.

the community residents; the physical examination population

Eligibility Criteria

• Age: 4 Years - 90 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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. \[families containing two or more family members (living together for more than 10 consecutive months per year) and the family members aged 3 years and above\];

You may qualify if:

• 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 \[families containing two or more family members (living together for more than 10 consecutive months per year) and the family members aged 3 years and above\];

You may not qualify if:

• 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;

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead
• The Second People's Hospital of Huaihua: collaborator
• Yueyang Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

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

Changsha, Hunan, 410013, China

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 20, 2024
• First Posted: May 3, 2024
• Study Start: April 20, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)