Comprehensive Management Strategies for Gastroesophageal Reflux Disease: A Study of Multidimensional Interventions and Health Impacts
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Gastroesophageal Reflux Disease Questionnaire（GERDQ）
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Dietary intervention guided by a nutritionist
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.
干预措施: Dietary intervention guided by a nutritionist (Behavioral)
Written dietary education intervention
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.
干预措施: Written dietary education intervention (Behavioral)
结局指标
主要结局
Gastroesophageal Reflux Disease Questionnaire（GERDQ）
时间窗: 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.
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.
Disease symptom index(DSI)
时间窗: 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.
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.
Global Symptom Severity Questionnaire(GSS)
时间窗: 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.
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.
Reflux Symptom Index(RSI)
时间窗: 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.
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.
Esophageal Hypervigilance and Anxiety Scale(EHAS)
时间窗: 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.
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.
Pittsburgh Sleep Quality Index(PSQI)
时间窗: 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.
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.
Taiwanese Depression Questionnaire(TDQ)
时间窗: 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.
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.
The State-Trait Anxiety Inventory(STAI)
时间窗: 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.
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.
Visceral sensitivity index(VSI)
时间窗: 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.
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.
Functional dyspepsia(FD)
时间窗: 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.
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.
Irritable bowel syndrome questionnaire(IBS)
时间窗: 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.
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.
Gastrointestinal Symptom Rating Scale(GSRS)
时间窗: 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.
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.
GERD Health-related Quality of Life (GERD-HRQL)
时间窗: 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.
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.
Short-form-12-health-survey-questionnaire(SF-12)
时间窗: 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.
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.
次要结局
未报告次要终点
研究者
Lei, Wei-Yi
Director of the Gastrointestinal Motility and Neurogastroenterology Department
Hualien Tzu Chi General Hospital