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Cognitive-behavioral Therapy for the Diseases Associated With Esophageal-brain-gut Axis Communication Abnormalities.

RecruitingNAAges 18 Years - 75 YearsAllHualien Tzu Chi General Hospital
NCT06939465 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Gastroesophageal reflux disease (GERD) is a challenging gastrointestinal disorder, and proton pump inhibitors (PPIs) are typically the first line of treatment. However, up to 40% of GERD patients experience little to no relief or only partial relief of their symptoms after receiving PPI therapy. Among these patients, who do not respond to high-dose PPIs taken twice daily, more than 90% exhibit conditions related to brain-gut axis communication disorders, such as esophageal hypersensitivity and functional heartburn. Visceral hypersensitivity and esophageal hypervigilance are the two key causes of esophageal symptoms in this group of patients. According to the Rome IV consensus on esophageal disorders, five categories are identified: functional chest pain, functional heartburn, globus sensation, functional dysphagia, and esophageal hypersensitivity. The diagnostic criteria state that patie

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age between 18 and 75 years, with clear consciousness and willingness to sign the informed consent form. 2. Subjects with chronic esophageal symptoms related to disorders of the brain-gut axis communication (such as heartburn, acid reflux, sensation of a foreign body in the throat, difficulty swallowing, and chest pain or discomfort). Exclusion Criteria: 1. Esophageal strictures, or history of surgery on the esophagus, gastrointestinal tract, or throat. 2. Structural esophageal diseases (such as diverticula, esophageal rings, etc.), infectious esophagitis, erosive esophagitis, eosinophilic esophagitis. 3. Non-erosive gastroesophageal reflux disease or significant esophageal motility disorders. 4. History of or current diagnosis of malignancies in the esophagus, gastrointestinal tract, or other organs. 5. Significant endocrine or rheumatic immune diseases that may affect gastrointestinal motility. 6. Continuous use of medications that may affect esophageal motility within the past month (such as anticholinergics, opioid-like agents, nitrates, calcium channel blockers, etc.). 7. Use of or currently taking antidepressants, selective serotonin reuptake inhibitors, or other psychotropic medications within the past three months. 8. Pregnant or breastfeeding women. 9. Individuals with mental illness or those who are unable to cooperate. 10. Known allergy to tricyclic antidepressants. 11. Known allergy to selective serotonin reuptake inhibitors. 12. Known allergy to any component of proton pump inhibitors.
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What it tests

  • Cognitive Behavioral Therapy (CBT)
  • Lifestyle management (sham control)
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Where

1 site
Hualien Tzu Chi Hospital,Buddhist Tzu Chi Medical Foundation
Hualien City, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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