Using neuromodulators to treat gut-brain communication disorders in GERD patients
Esophageal Visceral Hypersensitivity and Hypervigilance in Disorders of Gut-brain Interaction: the Roles of Neuromodulators
This study is testing if certain medications for mood can help people with GERD who haven't found relief from regular treatments feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 610 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hualien Tzu Chi General Hospital Academic / other |
| Locations | 1 site (Hualien City) |
| Trial ID | NCT06778824 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of neuromodulators, specifically tricyclic antidepressants (TCA) and selective serotonin reuptake inhibitors (SSRI), in treating patients with gastroesophageal reflux disease (GERD) who have not responded to standard proton pump inhibitor (PPI) therapy. Participants will complete a series of questionnaires assessing their symptoms and quality of life before being randomly assigned to one of three treatment groups: TCA, SSRI, or PPI for 12 weeks. The study aims to determine if these neuromodulators can alleviate chronic esophageal symptoms related to disorders of gut-brain interaction. A total of 210 participants will be recruited for this trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with chronic esophageal symptoms linked to gut-brain communication issues.
Not a fit: Patients with structural esophageal diseases or significant gastrointestinal motility disorders are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief for patients suffering from refractory GERD and related gut-brain disorders.
How similar studies have performed: While the use of neuromodulators in treating gut-brain disorders is promising, this specific approach in GERD patients is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hualien City
- Hualien Tzu Chi Hospital,Buddhist Tzu Chi Medical Foundation — Hualien City, Taiwan (Recruiting)
Study contacts
- Principal investigator: Gastroenterology attending physician Lei Wei-Yi — staff
- Study coordinator: Gastroenterology attending physician Lei Wei-Yi
- Email: hlmweb@tzuchi.com.tw
- Phone: 886-3-8561825ext13226
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.