Clinical trial NCT06585176: Epidemiological Studies and Risk Factor Analysis of GERD in Xiamen City
Official title: Epidemiological Studies and Risk Factor Analysis of Gastroesophageal Reflux Diseases in Xiamen City: a Multicenter Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastroesophageal Reflux Disease
Epidemiology
Risk Factors
Keywords: Gastroesophageal reflux diseases
Barrett esophageal
Lead sponsor: Zhongshan Hospital (Xiamen), Fudan University
Sponsor class: OTHER
First posted: 2024-09-05
Enrollment: 1600
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gastroesophageal reflux disease (GERD) is a common digestive disorder in the general population that primarily affects the esophagus and gastro-duodenum. Due to its prevalence, GERD has a significant impact on quality of life and healthcare costs.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The prevalence of GERD in Xiamen city
timeFrame: 3 months.
measure: The percentage of reflux esophagitis
timeFrame: 3 months.
measure: The percentage of Barrett esophagus
timeFrame: 3 months.
Secondary outcomes:
measure: The life quality of GERD patients who were diagnosed by endoscopy
timeFrame: 3 months.
measure: The sensitivity of GERD-Q for diagnosis of GERD
timeFrame: 3 months.
measure: The specificity of GERD-Q for diagnosis of GERD
timeFrame: 3 months.
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Zhongshan Hospital (Xiamen), Fudan University
state: Fujian
Study officials:
affiliation: Zhongshan Hospital (Xiamen), Fudan University
name: Wei Jiang, Doctor
role: STUDY_CHAIR
References:
citation: Katz PO, Dunbar KB, Schnoll-Sussman FH, Greer KB, Yadlapati R, Spechler SJ. ACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease. Am J Gastroenterol. 2022 Jan 1;117(1):27-56. doi: 10.14309/ajg.0000000000001538.
citation: Chen Y, Sun X, Fan W, Yu J, Wang P, Liu D, Song M, Liu S, Zuo X, Zhang R, Hou Y, Han S, Li Y, Zhang J, Li X, Ke M, Fang X. Differences in Dietary and Lifestyle Triggers between Non-Erosive Reflux Disease and Reflux Esophagitis-A Multicenter Cross-Sectional Survey in China. Nutrients. 2023 Jul 31;15(15):3400. doi: 10.3390/nu15153400.