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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06399562
• Other study ID #: FastI 22136
• Status: Completed
• Start date: April 20, 2024
• Est. completion date: April 30, 2024

Study information

• Verified date: April 2024
• Source: The Third Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1516
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Gender: All
• Age group: 4 Years to 90 Years

Eligibility

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;

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Pylori Infection
• Infections

Intervention

Diagnostic Test:
• 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.

Behavioral:
• 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.

Locations

Country	Name	City	State
China	outpatient department of gastroenterology of the Third Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
The Third Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Helicobacter pylori eradication rate	carbon-13 urea breath test	through study completion, an average of 1 week