Epidemiological Studies and Risk Factor Analysis of GERD in Xiamen City

NCT06585176 | Completed DMC

• 1 other identifier: ZYC-GERD2024
• Study Type: observational
• Target: 1,625
• Locations: 1 country
• Sites: 1

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.

Conditions

Epidemiology; Risk Factors; Gastroesophageal Reflux Disease

Keywords

Gastroesophageal reflux diseases; Barrett esophageal

Outcome Measures

Primary Outcomes (3)

• The prevalence of GERD in Xiamen city

  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.

  3 months.

• The percentage of reflux esophagitis

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

  3 months.

• The percentage of Barrett esophagus

  The percentage of paticipants diagnosed with pathological Barrett esophagus using endoscopy monitoring among patients with baseline symptom in gastroenterology department will be calculated.

  3 months.

Secondary Outcomes (3)

• The life quality of GERD patients who were diagnosed by endoscopy

  3 months.

• The sensitivity of GERD-Q for diagnosis of GERD

  3 months.

• The specificity of GERD-Q for diagnosis of GERD

  3 months.

Study Arms (1)

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.

Other: No intervention

Interventions

No intervention OTHER

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

Gastroesophageal Reflux Disease

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongshan Hospital (Xiamen), Fudan University: lead

Study Sites (1)

Zhongshan Hospital (Xiamen), Fudan University

Xiamen, Fujian, 361015, China

Location

Related Publications (2)

• 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.

  PMID: 34807007 RESULT

• 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.

  PMID: 37571337 RESULT

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Wei Jiang, Doctor

  Zhongshan Hospital (Xiamen), Fudan University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: September 5, 2024
• Study Start: August 1, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)