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

NCT07754721 | Recruiting

• 1 other identifier: TCRD114-033
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lifestyle and Dietary Interventions; Disorders of Gut-brain Interaction; Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (14)

• Gastroesophageal Reflux Disease Questionnaire（GERDQ）

  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 minimum score of the questionnaire is 0 and the maximum score is 18. The higher the score, the worse the gastroesophageal reflux symptoms.

  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)

  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 minimum score of the questionnaire is 0 and the maximum score is 16. The higher the score, the worse the gastroesophageal reflux symptoms.

  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)

  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 minimum score of the questionnaire is 0 and the maximum score is 100. The higher the score, the worse the gastroesophageal reflux symptoms.

  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)

  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 minimum score of the questionnaire is 0 and the maximum score is 45. The higher the score, the worse the gastroesophageal reflux symptoms.

  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)

  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 lowest score of the questionnaire is 0 and the highest score is 60. The higher the score, the more severe the esophageal hypervigilance and anxiety.

  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)

  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 lowest score of the questionnaire is 0 and the highest score is 21. The higher the score, the worse the sleep quality.

  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.

• Taiwanese Depression Questionnaire(TDQ)

  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 lowest score of the questionnaire is 0 and the highest score is 54. The higher the score, the higher the depression index.

  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)

  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 lowest score of the questionnaire is 1 and the highest score is 80. The higher the score, the more obvious the anxiety trait.

  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)

  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 lowest score of the questionnaire is 0 and the highest score is 75. The higher the score, the higher the visceral sensitivity.

  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)

  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. If any one of items 1, 4, 7, or 10 on the questionnaire scores more than 1 point and the symptoms have persisted for more than 6 months, the participant is classified as having FD.

  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)

  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. If the abdominal pain frequency score is greater than 4, persists for more than 6 months, and is associated with defecation, the participant is classified as having IBS.

  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)

  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 questionnaire score ranges from 1 to 60, with higher scores indicating more severe gastrointestinal symptoms.

  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)

  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 questionnaire score ranges from 0 to 77, with higher scores indicating poorer quality of life related to gastroesophageal reflux disease.

  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)

  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 results of the SF-12 health scale mainly include two total scores: physical health total score (PCS) and mental health total score (MCS). These two scores are used to measure an individual's health status in these two aspects. 1. Physical Health Score (PCS) and Mental Health Score (MCS) are usually expressed as standardized scores with a mean of 50 and a standard deviation of 10. 2. A higher score indicates better health, whereas a lower score indicates worse health.

  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.

Study Arms (2)

Dietary intervention guided by a nutritionist

ACTIVE COMPARATOR

A nutritionist will assess the participant's dietary habits and food intake to determine whether they may trigger gastroesophageal reflux, and will provide guidance on how to adjust the diet accordingly. There will be two sessions, each lasting 20 minutes, conducted at the start of the study and after 4 weeks.

Behavioral: Dietary intervention guided by a nutritionist

Written dietary education intervention

SHAM COMPARATOR

Participants will be provided with an educational leaflet based on the national healthy eating guidelines and will be instructed to adjust their diet according to its content.

Behavioral: Written dietary education intervention

Interventions

Written dietary education intervention BEHAVIORAL

Participants will be provided with an educational leaflet based on the national healthy eating guidelines and will be instructed to adjust their diet according to its content.

Written dietary education intervention

Dietary intervention guided by a nutritionist BEHAVIORAL

A nutritionist will assess the participant's dietary habits and food intake to determine whether they may trigger gastroesophageal reflux, and will provide guidance on how to adjust the diet accordingly. There will be two sessions, each lasting 20 minutes, conducted at the start of the study and after 4 weeks.

Dietary intervention guided by a nutritionist

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Hualien Tzu Chi General Hospital: lead

Study Sites (1)

Hualien Tzu Chi Hospital,Buddhist Tzu Chi Medical Foundation

Hualien City, Taiwan, 970, Taiwan

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Wei-Yi Lei Gastroenterology attending physician

CONTACT

+88638561825; hlmweb@tzuchi.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterology attending physician

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start: January 2, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)