Gastroesophageal reflux disease (GERD) is a common gastrointestinal disorder, with around 80% of patients experiencing nighttime symptoms. The prolonged nighttime reflux increases esophageal acid exposure, leading to complications like erosive esophagitis and extra-esophageal symptoms such as asthma and chronic cough. These symptoms disrupt sleep and affect daytime work and quality of life. Diet significantly influences GERD; high-fat foods, spicy foods, caffeine, carbonated beverages, and fermentable oligosaccharides disaccharides monosaccharides and polyols (FODMAPs) can worsen symptoms by lowering the pressure of the lower esophageal sphincter or delaying gastric emptying. Eating before bed or lying down immediately after meals can also aggravate symptoms. Treatment typically includes weight loss, bed elevation, smoking and alcohol cessation, avoiding meals before bedtime, and certain food restrictions. However, most dietary studies are observational, and there is limited evidence from randomized controlled trials. Proton pump inhibitors are standard treatments, but about 40% of patients do not achieve satisfactory symptom relief after treatment. Many of these patients suffer from disorders of gut-brain axis interaction (DGBI), characterized by visceral hypersensitivity and heightened esophageal vigilance. Additionally, these patients often have comorbid functional gastrointestinal disorders, increasing diagnostic complexity and leading to poor treatment outcomes. The interaction between visceral hypersensitivity, psychological distress, and central sensitization in GERD patients with functional gastrointestinal disorders remains unclear. This study aims to explore GERD symptoms and their influencing factors from multiple perspectives and propose non-pharmacological treatment strategies. The research focuses on nighttime reflux symptoms, dietary interventions, and the interaction between functional gastrointestinal disorders and GERD, providing empirical support to improve patients' symptoms and quality of life. The results of this study will help clarify the pathophysiological mechanisms related to GERD, esophageal DGBI, and functional gastrointestinal disorders. Additionally, the research findings will provide effective treatment strategies for patients with refractory reflux and DGBI in clinical settings.
Age range
18 Years – 79 Years
Sex
ALL
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Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Gastroesophageal Reflux Disease Questionnaire（GERDQ）
Timeframe: Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
Disease symptom index(DSI)
Timeframe: Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
Global Symptom Severity Questionnaire(GSS)
Timeframe: Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
Reflux Symptom Index(RSI)
Timeframe: Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
Esophageal Hypervigilance and Anxiety Scale(EHAS)
Timeframe: Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
Pittsburgh Sleep Quality Index(PSQI)
Timeframe: Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
Wei-Yi Lei Gastroenterology attending physician
Taiwanese Depression Questionnaire(TDQ)
Timeframe: Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
The State-Trait Anxiety Inventory(STAI)
Timeframe: Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
Visceral sensitivity index(VSI)
Timeframe: Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
Functional dyspepsia(FD)
Timeframe: Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
Irritable bowel syndrome questionnaire(IBS)
Timeframe: Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
Gastrointestinal Symptom Rating Scale(GSRS)
Timeframe: Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
GERD Health-related Quality of Life (GERD-HRQL)
Timeframe: Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.
Short-form-12-health-survey-questionnaire(SF-12)
Timeframe: Each participant will complete a questionnaire assessment at study entry, and again at Week 4 and at the end of the 12-week intervention period.