Status:
RECRUITING
Cognitive-behavioral Therapy for the Diseases Associated With Esophageal-brain-gut Axis Communication Abnormalities.
Lead Sponsor:
Hualien Tzu Chi General Hospital
Conditions:
Gut-Brain Disorders
GERD Without Erosive Esophagitis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 expe...
Detailed Description
All participants will undergo questionnaire assessments and heart rate variability (HRV) measurements prior to treatment. The questionnaires include the Gastroesophageal Reflux Disease Questionnaire (...
Eligibility Criteria
Inclusion
- Age between 18 and 75 years, with clear consciousness and willingness to sign the informed consent form.
- 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
- Esophageal strictures, or history of surgery on the esophagus, gastrointestinal tract, or throat.
- Structural esophageal diseases (such as diverticula, esophageal rings, etc.), infectious esophagitis, erosive esophagitis, eosinophilic esophagitis.
- Non-erosive gastroesophageal reflux disease or significant esophageal motility disorders.
- History of or current diagnosis of malignancies in the esophagus, gastrointestinal tract, or other organs.
- Significant endocrine or rheumatic immune diseases that may affect gastrointestinal motility.
- Continuous use of medications that may affect esophageal motility within the past month (such as anticholinergics, opioid-like agents, nitrates, calcium channel blockers, etc.).
- Use of or currently taking antidepressants, selective serotonin reuptake inhibitors, or other psychotropic medications within the past three months.
- Pregnant or breastfeeding women.
- Individuals with mental illness or those who are unable to cooperate.
- Known allergy to tricyclic antidepressants.
- Known allergy to selective serotonin reuptake inhibitors.
- Known allergy to any component of proton pump inhibitors.
Key Trial Info
Start Date :
April 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06939465
Start Date
April 2 2024
End Date
December 31 2025
Last Update
April 29 2025
Active Locations (1)
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1
Hualien Tzu Chi Hospital,Buddhist Tzu Chi Medical Foundation
Hualien City, Taiwan