Gastroesophageal Reflux DiseaseNCT06585176
Epidemiological Studies and Risk Factor Analysis of GERD in Xiamen City
An observational study of Gastroesophageal Reflux Disease and Epidemiology, run by Zhongshan Hospital (Xiamen), Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Gastroesophageal Reflux Disease, Epidemiology, Risk Factors
- Type of treatment
- Pill or oral medicine
- How many people
- 1,625 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital (Xiamen), Fudan University
Xiamen, Fujian, 361015
About this study
Official title: Epidemiological Studies and Risk Factor Analysis of Gastroesophageal Reflux Diseases in Xiamen City: a Cross-sectional Study
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.
Read the 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.
- Conditions
- Gastroesophageal Reflux Disease, Epidemiology, Risk Factors
- Being tested
- No intervention
- Keywords
- Gastroesophageal reflux diseases, Barrett esophageal
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This concerns a natural history study. No interventions will be used.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months.
The percentage of reflux esophagitis
The percentage of participants diagnosed with reflux esophagitis using endoscopy among patients with baseline symptoms.
Measured: 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.
Measured: 3 months.
Secondary outcomes (3)
The life quality of GERD patients who were diagnosed by endoscopy
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.
Measured: 3 months.
The sensitivity of GERD-Q for diagnosis of GERD
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.
Measured: 3 months.
The specificity of GERD-Q for diagnosis of GERD
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.
Measured: 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start1 Aug 2024
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,625 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongshan Hospital (Xiamen), Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yucheng Zhu, Zhongshan Hospital (Xiamen), Fudan University
- Investigators
- Wei Jiang, Doctor, Study chair, Zhongshan Hospital (Xiamen), Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585176
- Sponsor's protocol ID
- ZYC-GERD2024
- Status last verified
- Mar 2026
- First submitted
- 26 Aug 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34807007Chen 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.
PubMed 37571337
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Studies and Risk Factor Analysis of Gastroesophageal Reflux Diseases in Xiamen City: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06585176
- Acronym / sponsor ID
- ZYC-GERD2024
- Conditions
- Gastroesophageal Reflux Disease, Epidemiology, Risk Factors
- Keywords
- Gastroesophageal reflux diseases, Barrett esophageal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,625 participants (actual)
- Lead sponsor
- Zhongshan Hospital (Xiamen), Fudan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastroesophageal Reflux Disease | – | Other: No interventionGastroesophageal 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. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis concerns a natural history study. No interventions will be used. | Other | Gastroesophageal Reflux Disease |
Primary outcome
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.
The percentage of reflux esophagitis
Time frame: 3 months.
The percentage of participants diagnosed with reflux esophagitis using endoscopy among patients with baseline symptoms.
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.
3 secondary outcomes
The life quality of GERD patients who were diagnosed by endoscopy
Time frame: 3 months.
The sensitivity of GERD-Q for diagnosis of GERD
Time frame: 3 months.
The specificity of GERD-Q for diagnosis of GERD
Time frame: 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Results publication: PubMed 34807007Katz 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.
- Results publication: PubMed 37571337Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Jiang, Doctor study chair
Zhongshan Hospital (Xiamen), Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease and Epidemiology, run by Zhongshan Hospital (Xiamen), Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of GERD in Xiamen city (time frame: 3 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06585176, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.