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Completed

NCT Number: NCT06585176

Epidemiological Studies and Risk Factor Analysis of GERD in Xiamen City

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.

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Key information

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital (Xiamen), Fudan University

Xiamen, Fujian, 361015, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. The prevalence of GERD in Xiamen city

    Time frame: 3 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.

  2. The percentage of reflux esophagitis

    Time frame: 3 months.

    The percentage of participants diagnosed with reflux esophagitis using endoscopy among patients with baseline symptoms.

  3. The percentage of Barrett esophagus

    Time frame: 3 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 outcomes

  1. The life quality of GERD patients who were diagnosed by endoscopy

    Time frame: 3 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.

  2. The sensitivity of GERD-Q for diagnosis of GERD

    Time frame: 3 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.

  3. The specificity of GERD-Q for diagnosis of GERD

    Time frame: 3 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.

Sponsors and collaborators

Lead sponsor

Zhongshan Hospital (Xiamen), Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 5, 2024
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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