Actively Recruiting
Cognitive-behavioral Therapy for the Diseases Associated With Esophageal-brain-gut Axis Communication Abnormalities.
Led by Hualien Tzu Chi General Hospital · Updated on 2025-04-29
120
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 patients must have chronic esophageal symptoms, and any structural, inflammatory, or motility abnormalities must be excluded. Therefore, diagnosing brain-gut axis communication disorders in the esophagus requires upper gastrointestinal endoscopy, esophageal pH-impedance testing, and high-resolution esophageal manometry. Neuromodulators, which regulate peripheral and central pain sensitivity, are a cornerstone of pharmacological treatment for brain-gut axis communication disorders and associated symptoms. Additionally, growing evidence supports the use of brain-gut axis behavioral therapies, such as gut-directed hypnotherapy and cognitive behavioral therapy (CBT), to effectively treat these disorders. However, research on neuromodulators and CBT in brain-gut axis communication disorders remains limited, and their efficacy is still unclear. The aim of this study is to investigate the effectiveness and role of CBT in treating brain-gut axis communication disorders. The information gained from this research will help clarify the pathophysiological mechanisms related to brain-gut axis communication abnormalities and refractory GERD symptoms. Furthermore, the findings will guide the development of effective treatment strategies for patients with brain-gut axis communication disorders who do not respond to PPI therapy in clinical practice.
CONDITIONS
Official Title
Cognitive-behavioral Therapy for the Diseases Associated With Esophageal-brain-gut Axis Communication Abnormalities.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, with clear consciousness and willingness to sign the informed consent form.
- Chronic esophageal symptoms related to brain-gut axis communication disorders, such as heartburn, acid reflux, foreign body sensation in the throat, difficulty swallowing, and chest pain or discomfort.
You will not qualify if you...
- Esophageal strictures or history of surgery on the esophagus, gastrointestinal tract, or throat.
- Structural esophageal diseases like diverticula or esophageal rings, infectious esophagitis, erosive esophagitis, eosinophilic esophagitis.
- Non-erosive gastroesophageal reflux disease or significant esophageal motility disorders.
- History or current diagnosis of malignancies in the esophagus, gastrointestinal tract, or other organs.
- Significant endocrine or rheumatic immune diseases affecting gastrointestinal motility.
- Use of medications affecting esophageal motility in the past month (e.g., anticholinergics, opioids, nitrates, calcium channel blockers).
- Use of antidepressants, selective serotonin reuptake inhibitors, or other psychotropic medications within the past three months.
- Pregnant or breastfeeding women.
- Mental illness or inability to cooperate.
- Known allergy to tricyclic antidepressants.
- Known allergy to selective serotonin reuptake inhibitors.
- Known allergy to any component of proton pump inhibitors.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hualien Tzu Chi Hospital,Buddhist Tzu Chi Medical Foundation
Hualien City, Taiwan
Actively Recruiting
Research Team
W
Wei-Yi Lei Gastroenterology attending physician
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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