Esophageal Muscle Function Study for Acid Reflux
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of this treatment for acid reflux?
The study on 'Validation of Pharyngeal Acid Reflux Episodes Using Hypopharyngeal Multichannel Intraluminal Impedance-pH' suggests that the HMII-pH technique can effectively detect pharyngeal reflux, which is relevant for understanding acid reflux. Additionally, 'Combined impedance-manometry for the evaluation of esophageal disorders' indicates that high-resolution impedance-manometry (HRIM) has been used to assess esophageal motor function, which is related to acid reflux management.12345
Is the esophageal muscle function study for acid reflux safe for humans?
The techniques used in the study, such as high-resolution manometry (HRM) and impedance monitoring, have been used safely in humans for diagnosing esophageal and swallowing disorders. These methods are considered standard and have been used in both adults and children without significant safety concerns.12346
How does this treatment for acid reflux differ from other treatments?
This study focuses on using advanced diagnostic techniques like high-resolution impedance manometry (HRIM) and multichannel intraluminal impedance-pH (MII-pH) to better understand esophageal muscle function in acid reflux, which is different from traditional treatments that primarily focus on reducing stomach acid. These techniques provide a more detailed analysis of both acid and non-acid reflux, potentially leading to more personalized treatment approaches.24578
What is the purpose of this trial?
The overall goal is to define and characterize the manometric characteristics of UES incompetence associated with objectively documented pharyngeal reflux. The investigators will use endoscopic reflux detection as gold standard.
Research Team
Reza Shaker, MD
Principal Investigator
Medical College of Wisconsin
Eligibility Criteria
This trial is for adults aged 18-85 with asthma of varying severity, GERD with or without supra-esophageal symptoms like chronic cough or hoarseness, and Barrett's esophagus confirmed by biopsy. Excluded are those under 18 or over 85, active substance abusers, certain ENT disease histories, pregnant women, Lidocaine allergy sufferers, green food dye allergies, and acute asthma exacerbation patients.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Simulated Reflux Testing
Participants undergo simulated reflux perfusion of the esophagus to analyze UES, LES, and esophageal pressure responses
Endoscopic Evaluation
Endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing
Follow-up
Participants are monitored for safety and effectiveness after testing
Treatment Details
Interventions
- Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy
- Slow and rapid intra-esophageal infusion
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor