Disorders of Gut-brain InteractionNCT07754721
Comprehensive Management Strategies for Gastroesophageal Reflux Disease: A Study of Multidimensional Interventions and Health Impacts
A study testing Dietary intervention guided by a nutritionist and Written dietary education intervention in people with Disorders of Gut-brain Interaction and Lifestyle and Dietary Interventions, run by Hualien Tzu Chi General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Disorders of Gut-brain Interaction, Lifestyle and Dietary Interventions, Gastroesophageal Reflux Disease
- What is being tested?
- Dietary intervention guided by a nutritionist and Written dietary education intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Hualien Tzu Chi Hospital,Buddhist Tzu Chi Medical Foundation
Hualien City, Taiwan, 970
Wei-Yi Lei Gastroenterology attending physician, +88638561825 ext. 13224, hlmweb@tzuchi.com.tw
About this study
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
- Disorders of Gut-brain Interaction, Lifestyle and Dietary Interventions, Gastroesophageal Reflux Disease
- Being tested
- Dietary intervention guided by a nutritionist, Written dietary education intervention
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary intervention guided by a nutritionistBehavioural
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.
Written dietary education interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Written dietary education intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
- 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.
- A higher score indicates better health, whereas a lower score indicates worse health.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start2 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of Gut-brain InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hualien Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei, Wei-Yi, Hualien Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754721
- Sponsor's protocol ID
- TCRD114-033
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Management Strategies for Gastroesophageal Reflux Disease: A Study of Multidimensional Interventions and Health Impacts
- ClinicalTrials.gov ID
- NCT07754721
- Acronym / sponsor ID
- TCRD114-033
- Conditions
- Disorders of Gut-brain Interaction, Lifestyle and Dietary Interventions, Gastroesophageal Reflux Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Hualien Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary intervention guided by a nutritionist | Active comparator | Behavioral: Dietary intervention guided by a nutritionistA 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. |
| Written dietary education intervention | Sham comparator | Behavioral: Written dietary education interventionParticipants 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary intervention guided by a nutritionistA 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. | Behavioural | Dietary intervention guided by a nutritionist |
| Written dietary education interventionParticipants 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. | Behavioural | Written dietary education intervention |
Primary outcome
Gastroesophageal Reflux Disease Questionnaire（GERDQ）
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention guided by a nutritionist and Written dietary education intervention in people with Disorders of Gut-brain Interaction and Lifestyle and Dietary Interventions, run by Hualien Tzu Chi General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei-Yi Lei Gastroenterology attending physician (+88638561825 ext. 13224, hlmweb@tzuchi.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastroesophageal Reflux Disease Questionnaire（GERDQ） (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 study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.