Using neuromodulators to treat gut-brain communication disorders in GERD patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cognitive-behavioral therapy for gut-brain communication issues in GERD patients

  This study tests if cognitive-behavioral therapy can help people with GERD who don't get better with usual medications by improving how their brain and gut communicate.

  Recruiting Hualien Tzu Chi General Hospital · Hualien City · NCT06939465

• Managing GERD with personalized dietary changes and guided education

  A dietary plan and written education are being tested to see if they help adults with chronic GERD reduce symptoms.

  Recruiting Hualien Tzu Chi General Hospital · Hualien City, Taiwan · NCT07754721

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.