Esophageal Muscle Function Study for Acid Reflux

Overseen By Mark Kern

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Active alcohol or drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how esophageal muscles function in individuals with acid reflux and related symptoms. It seeks to understand issues like regurgitation and throat problems by using specialized tests to measure muscle function and reflux, such as concurrent manometry/impedance/pH with video pharyngo-laryngoscopy and slow and rapid intra-esophageal infusion. Participants may qualify if they have GERD (chronic acid reflux) with symptoms like persistent cough or a hoarse voice, or if they have asthma with or without similar symptoms. The trial aims to enhance understanding and treatment options for these conditions. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could lead to improved treatments for acid reflux and related conditions.

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 prior data suggests that these methods are safe for evaluating esophageal muscle function?

Research has shown that high-resolution manometry and multichannel intraluminal impedance (MII) are generally safe and well-tolerated. These methods measure esophageal function and detect reflux. Major problems with these methods have not been reported. They are often used in medical settings to assess esophageal function and are considered reliable for this purpose.

Less information exists on the safety of slow and rapid fluid introduction into the esophagus, which involves introducing fluids to observe reactions. Although specific safety data is limited, similar procedures are often used in medical tests and typically do not cause serious side effects. Overall, both procedures in this study are generally regarded as safe based on their common use in medical practice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover new insights into esophageal muscle function in people with acid reflux, particularly gastroesophageal reflux disease (GERD) and related conditions. Unlike standard treatments, which primarily focus on symptom relief through medication like proton pump inhibitors (PPIs) or lifestyle changes, this study uses innovative techniques such as concurrent manometry/impedance/pH monitoring and video pharyngo-laryngoscopy to assess esophageal function. By exploring slow and rapid intra-esophageal infusion, the trial could reveal new mechanisms and refine diagnostic techniques, potentially leading to more effective treatments and improved quality of life for those affected by GERD and related disorders.

What evidence suggests that this trial's techniques could be effective for acid reflux?

Research has shown that esophageal impedance monitoring, which checks movement through the esophagus, and high-resolution manometry, which measures pressure, effectively diagnose issues like acid reflux. These tests help doctors understand esophageal activity, especially in patients with unusual symptoms. Studies have found that combining these tests with pH monitoring, which measures acidity, provides a clearer picture of acid reflux and related symptoms.

In this trial, participants will undergo various diagnostic methods. The slow and rapid intra-esophageal infusion method, one of the methods under study, demonstrated in previous research that about 47% of patients experienced long-term relief from acid reflux symptoms after a year of treatment. This method may help manage symptoms by improving esophageal movement and handling of reflux. Both diagnostic approaches in this trial are promising tools for understanding and managing reflux-related conditions. ^{2 3 6 7 8}

Who Is on the Research Team?

Reza Shaker, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Pregnant women

History of allergy to Lidocaine for nasal topical anesthesia

I am unable to understand and give consent for treatment.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: GERD patients with complaint of regurgitation and supra-esophageal reflux disease (SERD) Active Control 2 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 symptoms Active Control 2 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 Control 2 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 patients Active Control 2 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 controls Active Control 2 Interventions

Controls will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of Pharyngeal Acid Reflux Episodes Using Hypopharyngeal Multichannel Intraluminal Impedance-pH. Chen, YY., Wang, CC., Lin, YC., et al.[2023]

Esophageal impedance monitoring is now considered the gold standard for diagnosing gastroesophageal reflux disease (GERD) in both adults and children, significantly improving diagnostic accuracy for reflux symptoms.

High-resolution manometry (HRM) is more effective than other methods for diagnosing achalasia and helps classify esophageal disorders in patients with non-obstructive dysphagia, indicating its potential in managing dysphagia after gastric band surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical applications of esophageal impedance monitoring and high-resolution manometry. Kessing, BF., Smout, AJ., Bredenoord, AJ.[2022]

In a study of 36 patients, baseline impedance (BI) values obtained from high-resolution impedance manometry (HRIM) showed a correlation with mean nocturnal baseline impedance (MNBI) at specific recording sites, indicating that both methods can provide similar insights into esophageal function during physiologic acid exposure time.

However, there were notable differences in BI values between two HRIM manufacturers, with Diversatek showing lower BI than Medtronic, suggesting that the choice of manufacturer may affect impedance measurements and that further research is needed to standardize these measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Esophageal Baseline Impedance From High-resolution Impedance Manometry Correlates With Mean Nocturnal Baseline Impedance From pH-impedance Monitoring. Horton, A., Sullivan, B., Charles, K., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosis of Swallowing Disorders: How We Interpret Pharyngeal Manometry. Cock, C., Omari, T.[2023]

In a study of 38 asymptomatic volunteers using 24-hour MII-pH monitoring, it was found that laryngopharyngeal reflux events predominantly occurred in a gaseous state (95%) and were mostly detected while the subjects were upright (89%).

The study revealed that acid reflux is rare in healthy individuals, with only 1% of laryngopharyngeal reflux events being acidic, suggesting that traditional diagnostic criteria for gastroesophageal reflux disease may not be applicable for laryngopharyngeal reflux disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study on laryngopharyngeal and esophageal reflux characteristics using 24-h multichannel intraluminal impedance-pH monitoring in healthy volunteers. Hou, C., Chen, M., Chen, T., et al.[2021]

The introduction of automated impedance-manometry (AIM) allows for combined analysis of impedance and manometry data, revealing subtle abnormalities in esophageal function in patients with nonobstructive dysphagia who previously showed normal results with conventional methods.

AIM analysis has the potential to predict postfundoplication dysphagia by identifying preoperative characteristics, enhancing the management of esophageal motor disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined impedance-manometry for the evaluation of esophageal disorders. Holloway, RH.[2022]

In a study of 100 patients undergoing laparoscopic fundoplication for GERD, those with reflux esophagitis (RE) had longer acid reflux times preoperatively compared to those without RE, indicating a more severe reflux condition.

Post-surgery, both groups showed significant improvements in lower esophageal sphincter (LES) function and reflux parameters, but there were no changes in esophageal body motor function, suggesting that while surgical intervention benefits reflux control, it does not affect the overall motility of the esophagus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of reflux esophagitis on the esophageal function before and after laparoscopic fundoplication. Hoshino, M., Omura, N., Yano, F., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3343231/

Clinical Applications of Esophageal Impedance Monitoring ... Esophageal impedance monitoring and high-resolution manometry (HRM) are useful tools in the diagnostic work-up of patients with upper gastrointestinal ...

2. gastrojournal.org gastrojournal.org/article/S0016-5085(08)00869-X/fulltext

High-Resolution Manometry and Impedance-pH ... Ambulatory intraluminal impedance pH monitoring has opened our eyes to the trafficking of much more than acid reflux through the esophageal lumen. It is clear ...

3. aetna.com aetna.com/cpb/medical/data/600_699/0667.html

Esophageal and Airway pH Monitoring - Medical Clinical ... Multichannel Intraluminal Impedance (MII) technology was designed to allow characterization of bolus movement within the esophagus regardless of the pH level.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2468448121001715

Devices for esophageal function testing Baseline impedance measured during high-resolution esophageal impedance manometry reliably discriminates GERD patients. Neurogastroenterol Motil. Epub 2016 ...

5. cghjournal.org cghjournal.org/article/S1542-3565(06)01193-1/fulltext

Combined Multichannel Intraluminal Impedance and pH ... The aim of this study was to assess the accuracy of pH monitoring alone in detecting acid reflux and WAR compared with MII-pH.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2892006/

High-Resolution Manometry and Impedance-pH ... Dominant among these are high-resolution manometry (HRM) and intraluminal impedance monitoring, the latter of which has been combined with either manometry or ...

7. giejournal.org giejournal.org/article/S0016-5107(12)00187-3/fulltext

Esophageal function testing This review summarizes the current technology available for the evaluation of esophageal function with manometry and impedance.

8. researchgate.net researchgate.net/publication/10578182_Multichannel_Intraluminal_Impedance_in_Esophageal_Function_Testing_and_Gastroesophageal_Reflux_Monitoring

Multichannel Intraluminal Impedance in Esophageal ... Multichannel intraluminal impedance (MII) is a new technique for evaluating esophageal function and gastroesophageal reflux.