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

4. september 2026 opdateret af: Lei, Wei-Yi, Hualien Tzu Chi General Hospital
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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

220

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Wei-Yi Lei Gastroenterology attending physician
  • Telefonnummer: 13224 +88638561825
  • E-mail: hlmweb@tzuchi.com.tw

Studiesteder

  • Taiwan
    • Taiwan
      • Hualien City, Taiwan, Taiwan, 970
        • Rekruttering
        • Hualien Tzu Chi Hospital,Buddhist Tzu Chi Medical Foundation
        • Kontakt:
          • Wei-Yi Lei Gastroenterology attending physician
          • Telefonnummer: 13224 +88638561825
          • E-mail: hlmweb@tzuchi.com.tw

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Aged 18-79 years, mentally alert, and willing to provide written informed consent.
  2. Individuals with chronic gastroesophageal reflux symptoms (acid regurgitation, chest pain, or heartburn) who are willing to undergo dietary intervention.

Exclusion Criteria:

  1. Individuals with esophageal stricture, current or prior diagnosis of esophageal tumors, or a history of esophageal, upper gastrointestinal, or pharyngeal surgery.
  2. Individuals with structural esophageal disorders (e.g., diverticulum, esophageal rings), infectious esophagitis, or eosinophilic esophagitis.
  3. Individuals with major esophageal motility disorders.
  4. Individuals taking medications that may affect esophageal motility (e.g., opioids, nitrates, calcium channel blockers).
  5. 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.
  6. Pregnant women, or individuals unable to comply with lifestyle and dietary interventions for other reasons.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Adfærdsmæssigt: 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.
Sham-komparator: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gastroesophageal Reflux Disease Questionnaire（GERDQ）
Tidsramme: 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.
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)
Tidsramme: 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.
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)
Tidsramme: 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.
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)
Tidsramme: 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.
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)
Tidsramme: 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.
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)
Tidsramme: 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.
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)
Tidsramme: 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.
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)
Tidsramme: 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.
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)
Tidsramme: 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.
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)
Tidsramme: 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.
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)
Tidsramme: 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.
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)
Tidsramme: 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.
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)
Tidsramme: 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.
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)
Tidsramme: 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.
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hualien Tzu Chi General Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. januar 2025

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

5. august 2026

Først indsendt, der opfyldte QC-kriterier

5. august 2026

Først opslået (Faktiske)

10. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. september 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TCRD114-033

Plan for individuelle deltagerdata (IPD)

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