Comprehensive Management Strategies for Gastroesophageal Reflux Disease: A Study of Multidimensional Interventions and Health Impacts

Recruiting now · Not applicable

Conditions studied: Disorders of Gut-brain Interaction, Lifestyle and Dietary Interventions, Gastroesophageal Reflux Disease

In brief

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.

Key facts

Study ID

NCT07754721

Run by

Hualien Tzu Chi General Hospital

People needed

220

Starts

2025-01-02

Expected to finish

2026-12-31

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18-79 years, mentally alert, and willing to provide written informed consent.
• Individuals with chronic gastroesophageal reflux symptoms (acid regurgitation, chest pain, or heartburn) who are willing to undergo dietary intervention.

You may not qualify if…

• Individuals with esophageal stricture, current or prior diagnosis of esophageal tumors, or a history of esophageal, upper gastrointestinal, or pharyngeal surgery.
• Individuals with structural esophageal disorders (e.g., diverticulum, esophageal rings), infectious esophagitis, or eosinophilic esophagitis.
• Individuals with major esophageal motility disorders.
• Individuals taking medications that may affect esophageal motility (e.g., opioids, nitrates, calcium channel blockers).
• Individuals who have used antidepressants, selective serotonin reuptake inhibitors (SSRIs), or other psychiatric medications continuously within the past three months, or are currently taking them.
• Pregnant women, or individuals unable to comply with lifestyle and dietary interventions for other reasons.

Where it is running

• Hualien Tzu Chi Hospital,Buddhist Tzu Chi Medical Foundation — Hualien City, Taiwan, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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