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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Gut-Brain Disorders, GERD Without Erosive Esophagitis

In brief

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.

Key facts

Study ID

NCT06939465

Run by

Hualien Tzu Chi General Hospital

People needed

120

Starts

2024-04-02

Expected to finish

2025-12-31

Last updated by the study team

2025-04-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Hualien Tzu Chi Hospital,Buddhist Tzu Chi Medical Foundation — Hualien City, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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