Epidemiological Studies and Risk Factor Analysis of GERD in Xiamen City

NCT ID: NCT06585176

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Gastroesophageal Reflux Disease Epidemiology Risk Factors

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Gastroesophageal Reflux Disease

Gastroesophageal reflux disease (GERD) is a gastrointestinal motility disorder that results from the reflux of stomach contents into the esophagus or oral cavity resulting in symptoms or complications.

No intervention

Intervention Type OTHER

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

Interventions

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No intervention

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhongshan Hospital (Xiamen), Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Zhuyucheng

Deputy Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Jiang, Doctor

Role: STUDY_CHAIR

Zhongshan Hospital (Xiamen), Fudan University

Locations

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Zhongshan Hospital (Xiamen), Fudan University

Xiamen, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yucheng Zhu, Doctor

Role: CONTACT

86-592-3501990

Wei Jiang, Doctor

Role: CONTACT

86-592-3501990

Facility Contacts

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Yucheng Zhu, Doctor

Role: primary

+865923501990

References

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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.

Reference Type RESULT
PMID: 34807007 (View on PubMed)

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.

Reference Type RESULT
PMID: 37571337 (View on PubMed)

Other Identifiers

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ZYC-GERD2024

Identifier Type: -

Identifier Source: org_study_id

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