Esophageal Visceral Hypersensitivity and Hypervigilance in Disorders of Gut-brain Interaction: the Roles of Cognitive-behavioral Therapy

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Taiwan
Hualien Tzu Chi Hospital,Buddhist Tzu Chi Medical Foundation
RECRUITING
Hualien City
Contact Information
Primary
Wei-Yi Lei Gastroenterology attending physician
hlmweb@tzuchi.com.tw
+88638561825
Time Frame
Start Date: 2024-04-02
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 120
Treatments
Active_comparator: Cognitive behavioral therapy (CBT)
Cognitive Behavioral Therapy (CBT) will be implemented according to the following steps: (1) Psychoeducation and beginning of tracking; (2) Introduction to heart rate variability and breathing; (3) Cognitive restructuring and breathing application; (4) Cognitive defusion and behavioral experiments; (5) Coping strategies for problem-focused and emotion-focused approaches; (6) Conclusion of therapy and relapse prevention.
Sham_comparator: Lifestyle management (sham control)
Lifestyle management (sham control) will be implemented according to the following steps: (1) Psychoeducation and beginning of tracking; (2) Dietary habits: What, when, where, and why; (3) Changing my diet: Strategies and barriers; (4) Lifestyle factors: Alcohol, smoking, and sugar; (5) Lifestyle factors: Sleep and exercise; (6) Conclusion of therapy and relapse prevention.
Sponsors
Leads: Hualien Tzu Chi General Hospital

This content was sourced from clinicaltrials.gov