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Neuroregulators for the Treatment of Diseases Associated With Esophageal-brain-gut Axis Communication Abnormalities.

RecruitingNAAges 18 Years - 75 YearsAllHualien Tzu Chi General Hospital
NCT06778824 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Gastroesophageal reflux disease (GERD) poses a challenging medical condition to manage, with up to 40% of patients showing refractory to standard medical intervention, which usually begins with a proton pump inhibitor (PPI). Among these cases, esophageal disorders of gut-brain interaction (DGBI), such as reflux hypersensitivity and functional heartburn, or GERD patients with concurrent occurrences of these conditions, constitute more than 90% of the patients who did not respond to twice-daily PPI treatment. Esophageal visceral hypersensitivity and hypervigilance are the two pathways that drive esophageal DGBI and symptoms. The Rome IV esophageal disorders, encompassing functional chest pain, functional heartburn, globus, functional dysphagia, and reflux hypersensitivity, are defined by present with symptoms originating from the esophagus without detectable evidence of structural, inflamm

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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

  • Takepron
  • Zoloft 50Mg Tablet
  • Imipramine Pill
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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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