RecruitingNot ApplicableNCT07754721

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


Sponsor

Hualien Tzu Chi General Hospital

Enrollment

220 participants

Start Date

Jan 2, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Dietary intervention guided by a nutritionist and a behavioral approach called Written dietary education intervention for people with disorders of gut-brain interaction, gastroesophageal reflux disease, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 79 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALDietary 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.

BEHAVIORALWritten 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.


Locations(1)

Hualien Tzu Chi Hospital,Buddhist Tzu Chi Medical Foundation

Hualien City, Taiwan, Taiwan

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NCT07754721


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