Skip to content

Epidemiological Studies and Risk Factor Analysis of GERD in Xiamen City

Epidemiological Studies and Risk Factor Analysis of Gastroesophageal Reflux Diseases in Xiamen City: a Cross-sectional Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06585176
Enrollment
1625
Registered
2024-09-05
Start date
2024-08-01
Completion date
2025-10-31
Last updated
2026-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidemiology, Gastroesophageal Reflux Disease, Risk Factors

Keywords

Gastroesophageal reflux diseases, Barrett esophageal

Brief summary

Gastroesophageal Reflux Disease (GERD) is a condition characterized by the reflux of gastric and duodenal contents into the esophagus, primarily manifested by symptoms such as acid regurgitation and heartburn. GERD significantly affects patients' daily lives and health-related quality of life. Prolonged gastroesophageal reflux can lead to repeated irritation of the esophageal mucosa by gastric acid and acidic gastric contents, resulting in the replacement of normal squamous epithelium in the lower esophagus with metaplastic columnar epithelium. This pathological change, known as Barrett's Esophagus (BE), is considered a precancerous lesion for esophageal adenocarcinoma.

Detailed description

GERD is a common gastrointestinal disorder with numerous risk factors that negatively impact patients' quality of life. Abnormal psychological conditions may influence various aspects of GERD, including its onset, diagnosis, treatment, and prognosis. The incidence and risk factors of GERD vary in different countries or regions. Currently, there is a lack of unified national epidemiological data on GERD in China. Conducting epidemiological studies on GERD in China to identify risk factors and develop prevention and treatment measures tailored to the country's or specific regions' circumstances is crucial for reducing the incidence of GERD and improving patients' quality of life. In the context of the modern biomedical model of "biopsychosocial" health, actively researching the psychological conditions of patients, while also addressing their physical ailments and providing psychological treatment, emphasizes holistic care. This approach may comprehensively alleviate disease symptoms and enhance quality of life, potentially leading to new breakthroughs in the treatment of GERD. Based on this, a specialized cohort for gastroesophageal reflux disease will be established, along with multicenter epidemiological and clinical research in the Xiamen area. This initiative will help clarify the etiology of GERD and provide firsthand resources for evidence-based prevention and treatment.

Interventions

OTHERNo intervention

This concerns a natural history study. No interventions will be used.

Sponsors

Zhongshan Hospital (Xiamen), Fudan University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* All patients had experienced typical reflux symptoms, i.e., mild heartburn and/or regurgitation symptoms, for at least 2 days per week or moderate/severe reflux symptoms for more than 1 day per week during the previous 3 months and had upper endoscopy examinations in the previous month. * Cooperate with the questionnaire survey. * Volunteer and sign the informed consent form. * Permanent residents in Xiamen.

Exclusion criteria

* Malignant tumor. * Partial or total gastrectomy. * Failing to cooperate with the investigation because of the factors such as education level and language intelligence disorder, etc. * Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine and mental system diseases. * Patients with mental retardation, etc.

Design outcomes

Primary

MeasureTime frameDescription
The prevalence of GERD in Xiamen city3 months.Gastroesophageal reflux disease (GERD) is the most prevalent gastrointestinal disorder in the world. In this study, we will study the incidence of GERD in Xiamen city.
The percentage of reflux esophagitis3 months.The percentage of participants diagnosed with reflux esophagitis using endoscopy among patients with baseline symptoms.
The percentage of Barrett esophagus3 months.The percentage of paticipants diagnosed with pathological Barrett esophagus using endoscopy monitoring among patients with baseline symptom in gastroenterology department will be calculated.

Secondary

MeasureTime frameDescription
The life quality of GERD patients who were diagnosed by endoscopy3 months.The life quality of GERD patients with different main symptoms before PPI test will be measured via the 50-item short form health survey , in which higher scores mean a better quality of life.
The sensitivity of GERD-Q for diagnosis of GERD3 months.The sensitivity of GERD-Q for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the gold standard for the diagnosis of GERD.
The specificity of GERD-Q for diagnosis of GERD3 months.The specificity of GERD-Q for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the gold standard for the diagnosis of GERD.

Countries

China

Contacts

STUDY_CHAIRWei Jiang, Doctor

Zhongshan Hospital (Xiamen), Fudan University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026