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

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

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Diagnostic test: carbon-13 urea breath test (13C-UBT); Behavioral: questionnaires

• Study Type: Observational
• Enrollment (Actual): 1516

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • outpatient department of gastroenterology of the Third Xiangya Hospital of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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];

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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.
the community residents; the family-based community residents in Changsha	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Helicobacter pylori eradication rate	carbon-13 urea breath test	through study completion, an average of 1 week

Collaborators and Investigators

• Sponsor: The Third Xiangya Hospital of Central South University
• Collaborators: The Second People's Hospital of Huaihua; Yueyang Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2024
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: April 20, 2024
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 29, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: FastI 22136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No