An interventional study of Dietary intervention guided by a nutritionist and Written dietary education intervention in Disorders of Gut-brain Interaction, Lifestyle and Dietary Interventions and Gastroesophageal Reflux Disease, sponsored by Hualien Tzu Chi General Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Hualien Tzu Chi General Hospital · Not applicable, Interventional, and Treatment
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.
1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
This study's planned enrollment of 220 is above the median of 68 across 796 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Hualien Tzu Chi General Hospital is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hualien Tzu Chi General Hospital