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Neuroregulators for the Treatment of Diseases Associated With Esophageal-brain-gut Axis Communication Abnormalities.

NCT06778824 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 610

Last updated 2025-01-27

No results posted yet for this study

Summary

Gastroesophageal reflux disease (GERD) poses a challenging medical condition to manage, with up to 40% of patients showing refractory to standard medical intervention, which usually begins with a proton pump inhibitor (PPI). Among these cases, esophageal disorders of gut-brain interaction (DGBI), such as reflux hypersensitivity and functional heartburn, or GERD patients with concurrent occurrences of these conditions, constitute more than 90% of the patients who did not respond to twice-daily PPI treatment. Esophageal visceral hypersensitivity and hypervigilance are the two pathways that drive esophageal DGBI and symptoms. The Rome IV esophageal disorders, encompassing functional chest pain, functional heartburn, globus, functional dysphagia, and reflux hypersensitivity, are defined by present with symptoms originating from the esophagus without detectable evidence of structural, inflammatory, or motor disorders. Diagnosing esophageal DGBI necessitates testing involving endoscopy, pH-impedance monitoring, and high-resolution manometry. Neuromodulators form the basis of the pharmacological strategy for managing various esophageal DGBI and symptoms, modulating both peripheral and central hyperalgesia. Increasing evidence supports the use of brain-gut behavioral therapies, such as gut-directed hypnotherapy and cognitive behavior therapy, as effective treatments for a variety of DGBIs. However, the efficacy of neuromodulators in treating esophageal DGBI and related symptoms remains largely unexplored. The primary objective of this study is to examine the efficacy of neuromodulators in managing esophageal DGBI. Additionally, investigators will explore various classes of neuromodulators and subtypes of esophageal DGBI to ascertain whether there are differing levels of effectiveness across these conditions. The findings from this study will contribute to a better understanding of the pathophysiology of esophageal DGBI and GERD with refractory symptoms. These clinical insights may then offer valuable guidance for future therapeutic approaches in DGBI patients who experience esophageal symptoms and do not respond to PPI treatment.

Conditions

  • Gut-Brain Disorders
  • GERD Without Erosive Esophagitis

Interventions

DRUG

Takepron

Participants are expected to take a proton-pump inhibitor (PPI) for 12 weeks, with a dosage of 30 mg taken once a day.

DRUG

Zoloft 50Mg Tablet

Participants are expected to take a selective serotonin reuptake inhibitor (SSRI) for 12 weeks, with a dosage of 50 mg taken once a day.

DRUG

Imipramine Pill

Participants are expected to take tricyclic antidepressants (TCA) for 12 weeks, with a dosage of 25 mg taken twice a day.

Sponsors & Collaborators

  • Hualien Tzu Chi General Hospital

    lead OTHER

Principal Investigators

  • Gastroenterology attending physician Lei Wei-Yi · staff

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-02
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06778824 on ClinicalTrials.gov