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

4 de setembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

220

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Wei-Yi Lei Gastroenterology attending physician
  • Número de telefone: 13224 +88638561825
  • E-mail: hlmweb@tzuchi.com.tw

Locais de estudo

  • Taiwan
    • Taiwan
      • Hualien City, Taiwan, Taiwan, 970
        • Recrutamento
        • Hualien Tzu Chi Hospital,Buddhist Tzu Chi Medical Foundation
        • Contato:
          • Wei-Yi Lei Gastroenterology attending physician
          • Número de telefone: 13224 +88638561825
          • E-mail: hlmweb@tzuchi.com.tw

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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.
Comportamental: 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.
Comparador Falso: 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.
Comportamental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Gastroesophageal Reflux Disease Questionnaire（GERDQ）
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Hualien Tzu Chi General Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

2 de janeiro de 2025

Conclusão Primária (Estimado)

31 de dezembro de 2026

Conclusão do estudo (Estimado)

31 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

5 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de agosto de 2026

Primeira postagem (Real)

10 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de setembro de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • TCRD114-033

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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