Esophageal Muscle Function Study for Acid Reflux
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medical College of Wisconsin
Disqualifiers: Active alcohol or drug abuse, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
12346How 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.
24578Eligibility 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
I have asthma without a current severe flare-up.
I have GERD with symptoms like heartburn and throat issues.
I have been diagnosed with gastroesophageal reflux disease.
+4 more
Exclusion Criteria
I am younger than 18 or older than 85.
Pregnant women
History of allergy to Lidocaine for nasal topical anesthesia
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Simulated Reflux Testing
Participants undergo simulated reflux perfusion of the esophagus to analyze UES, LES, and esophageal pressure responses
During testing sessions
Multiple visits for testing
Endoscopic Evaluation
Endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing
1-2 weeks
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after testing
4 weeks
Participant Groups
The study tests how well the upper esophageal sphincter works to prevent acid reflux into the throat. It involves slow and rapid infusions in the esophagus while monitoring pressure changes and pH levels alongside video imaging of the throat area.
5Treatment groups
Active Control
Group I: GERD patients with complaint of regurgitation and supra-esophageal reflux disease (SERD)Active Control2 Interventions
GERD patients with complaint of regurgitation and one of the following supra-esophageal symptoms attributed to reflux of gastric content: chronic cough, frequent throat clearing, history of non-deglutitive aspiration pneumonia, hoarse voice, chronic sinusitis and dental erosion i.e. SE-GERD. Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.
Group II: Asthma patients with and without supra-esophageal symptomsActive Control2 Interventions
Asthma patients with and without supra-esophageal symptoms (these symptoms include chronic cough, frequent throat clearing, history of non-deglutitive aspiration pneumonia, hoarse voice, chronic sinusitis, and dental erosion). Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.
Group III: Age and gender matched patient controls (GERD without regurgitation and supra-esophageal complaint)Active Control2 Interventions
Age and gender matched patient controls (GERD without regurgitation and supra-esophageal complaint). Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.
Group IV: Age and gender matched patient controls for diagnosed Barrett's esophagus patientsActive Control2 Interventions
Patient controls for diagnosed Barrett's esophagus patients. Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.
Group V: Age and gender matched healthy controlsActive Control2 Interventions
Controls will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Medical College of WisconsinMilwaukee, WI
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Who Is Running the Clinical Trial?
Medical College of WisconsinLead Sponsor
References
A systematic review of current methodology of high resolution pharyngeal manometry with and without impedance. [2020]This systematic review appraises and summaries methodology documented in studies using high resolution pharyngeal manometry (HRM) with and without impedance technology (HRIM) in adult populations.
Validation of Pharyngeal Acid Reflux Episodes Using Hypopharyngeal Multichannel Intraluminal Impedance-pH. [2023]Hypopharyngeal multichannel intraluminal impedance-pH (HMII-pH) technology incorporating 2 trans-upper esophageal sphincter impedance channels has been developed to detect pharyngeal reflux. We used the HMII-pH technique to validate the candidate pharyngeal acid reflux (PAR) episodes based on the dual-pH tracings and determined the interobserver reproducibility.
Diagnosis of Swallowing Disorders: How We Interpret Pharyngeal Manometry. [2023]We provide an overview of the clinical application of novel pharyngeal high-resolution impedance manometry (HRIM) with pressure flow analysis (PFA) in our hands with example cases.
Combined impedance-manometry for the evaluation of esophageal disorders. [2022]Combined impedance-manometry was introduced just over 20 years ago for the assessment of esophageal motor function. Since then, technical developments have led to the introduction of high-resolution impedance-manometry (HRIM). However, analysis of the impedance and manometry recordings has remained separate and relatively unchanged since the introduction of HRIM, and it is unclear whether the addition of impedance has had a significant impact on the management of esophageal motor disorders.
Study on laryngopharyngeal and esophageal reflux characteristics using 24-h multichannel intraluminal impedance-pH monitoring in healthy volunteers. [2021]We aimed to analyze the results of 24-h multichannel intraluminal impedance and pH-monitoring (MII-pH) of the laryngopharynx and esophagus in asymptomatic volunteers. Moreover, we also aimed to gain insight into and establish a baseline for laryngopharyngeal reflux in the healthy population by quantitatively and qualitatively comparing the reflux and pH distribution in both the laryngopharynx and the esophagus.
Clinical applications of esophageal impedance monitoring and high-resolution manometry. [2022]Esophageal impedance monitoring and high-resolution manometry (HRM) are useful tools in the diagnostic work-up of patients with upper gastrointestinal complaints. Impedance monitoring increases the diagnostic yield for gastroesophageal reflux disease in adults and children and has become the gold standard in the diagnostic work-up of reflux symptoms. Its role in the work-up for belching disorders and rumination seems promising. HRM is superior to other diagnostic tools for the evaluation of achalasia and contributes to a more specific classification of esophageal disorders in patients with non-obstructive dysphagia. The role of HRM in patients with dysphagia after laparoscopic placement of an adjustable gastric band seems promising. Future studies will further determine the clinical implications of the new insights which have been acquired with these techniques. This review aims to describe the clinical applications of impedance monitoring and HRM.
Impact of reflux esophagitis on the esophageal function before and after laparoscopic fundoplication. [2019]High-resolution manometry (HRM), which is breakthrough testing equipment to evaluate esophageal motor function, was developed in Europe and United State and has garnered attention. Moreover, multichannel intraluminal impedance pH (MII-pH) testing has allowed us to grasp all liquid/gas reflux including not only acid but also non-acid reflux. We examined the impact of the presence of reflux esophagitis (RE) on esophageal motor function before and after laparoscopic fundoplication.
Esophageal Baseline Impedance From High-resolution Impedance Manometry Correlates With Mean Nocturnal Baseline Impedance From pH-impedance Monitoring. [2020]Esophageal baseline impedance (BI) can be extracted from pH-impedance tracings as mean nocturnal baseline impedance (MNBI), and from high-resolution impedance manometry (HRIM), but it is unknown if values are similar between acquisition methods across HRIM manufacturers. We aim to assess correlations between MNBI and BI from HRIM (BI-HRIM) from 2 HRIM manufacturers in the setting of physiologic acid exposure time (AET).