300 Participants Needed

Esophageal Muscle Function Study for Acid Reflux

RS
MK
Overseen ByMark Kern
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medical College of Wisconsin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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 | Froedtert & the ...

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

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.
See 3 more

Exclusion Criteria

Pregnant women
History of allergy to Lidocaine for nasal topical anesthesia
I am unable to understand and give consent for treatment.
See 5 more

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

Treatment Details

Interventions

  • Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy
  • Slow and rapid intra-esophageal infusion
Trial Overview 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.
Participant Groups
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

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+

Findings from Research

A systematic review of 62 studies on high resolution pharyngeal manometry (HRM) and high resolution impedance manometry (HRIM) revealed significant variability in methodology, which can hinder the ability to replicate studies and compare results effectively.
Most studies used the ManoScan™ system and reported the use of topical anesthesia, but only a small percentage provided data on measurement reliability, highlighting a need for improved methodological reporting in future research.
A systematic review of current methodology of high resolution pharyngeal manometry with and without impedance.Winiker, K., Gillman, A., Guiu Hernandez, E., et al.[2020]
In a study involving 90 patients with suspected laryngopharyngeal reflux and 28 healthy volunteers, the HMII-pH technology successfully identified 80% of candidate pharyngeal acid reflux episodes as confirmed cases, indicating its efficacy in detecting pharyngeal reflux.
The interobserver reproducibility for diagnosing these episodes was high at 92.2%, suggesting that the HMII-pH method provides reliable results across different observers.
Validation of Pharyngeal Acid Reflux Episodes Using Hypopharyngeal Multichannel Intraluminal Impedance-pH.Chen, YY., Wang, CC., Lin, YC., et al.[2023]
Pharyngeal high-resolution impedance manometry (HRIM) is now a practical tool for assessing swallowing dysfunction, providing both qualitative and quantitative measures of swallow function, including the swallow risk index (SRI) and post-swallow impedance ratio (PSIR).
The use of HRIM can help identify specific issues in swallowing mechanics, such as pressure and timing in the hypopharynx and upper esophageal sphincter, which may guide treatment strategies and improve patient outcomes.
Diagnosis of Swallowing Disorders: How We Interpret Pharyngeal Manometry.Cock, C., Omari, T.[2023]

References

A systematic review of current methodology of high resolution pharyngeal manometry with and without impedance. [2020]
Validation of Pharyngeal Acid Reflux Episodes Using Hypopharyngeal Multichannel Intraluminal Impedance-pH. [2023]
Diagnosis of Swallowing Disorders: How We Interpret Pharyngeal Manometry. [2023]
Combined impedance-manometry for the evaluation of esophageal disorders. [2022]
Study on laryngopharyngeal and esophageal reflux characteristics using 24-h multichannel intraluminal impedance-pH monitoring in healthy volunteers. [2021]
Clinical applications of esophageal impedance monitoring and high-resolution manometry. [2022]
Impact of reflux esophagitis on the esophageal function before and after laparoscopic fundoplication. [2019]
Esophageal Baseline Impedance From High-resolution Impedance Manometry Correlates With Mean Nocturnal Baseline Impedance From pH-impedance Monitoring. [2020]
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