Understanding how to prevent pharyngeal reflux in GERD patients
Pathophysiology of Pharyngo-esophageal Junction and Esophageal Mechanisms Preventing Pharyngeal Reflux of Gastric Content
This study is trying to understand how the muscles in the throat work in people with GERD to see if they can help prevent reflux from reaching the throat.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Medical College of Wisconsin Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT05696184 on ClinicalTrials.gov |
What this trial studies
This study aims to define and characterize the pressure responses of the upper esophageal sphincter (UES) in patients with gastroesophageal reflux disease (GERD) who experience pharyngeal reflux. It will utilize endoscopic reflux detection as the gold standard to assess differences in UES pressure responses to liquid refluxate among various patient groups. The study will also investigate the role of the proximal striated esophagus in preventing reflux and how esophageal motor activity is affected by reflux events. By comparing patients with GERD and those without, the study seeks to identify specific mechanisms that contribute to pharyngeal reflux.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 85 with GERD who experience regurgitation and supra-esophageal symptoms, as well as asthma patients with varying severity classifications.
Not a fit: Patients with acute asthma exacerbations or those outside the age range of 18 to 85 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients suffering from GERD and associated pharyngeal reflux symptoms.
How similar studies have performed: While the specific approach of this study may be novel, similar studies have shown promise in understanding reflux mechanisms and their impact on patient symptoms.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 to 85 * GERD patients with complaints of regurgitation and supra-esophageal symptoms will be included and recruited from our GI \& Otolaryngology clinics * GERD patients without complaint of supra-esophageal symptoms and regurgitation will be included and recruited from our GI \& Otolaryngology clinics * Asthma patients with and without supra-esophageal symptoms will be included and recruited from clinics affiliated with Medical College of Wisconsin. Asthma patients with the following classifications of asthma severity will be included: intermittent, mild persistent, moderate persistent, and severe persistent (as long as no acute asthma exacerbation at the time of the study) * Patient definition will be based on position statement and technical reviews of the American Gastroenterological Association and Montreal definition and classification of gastroesophageal and reflux disease (Am J Gastroenterol. 2006;101:1900-1920). * SERD is defined as patients on long term acid suppressive therapy complaining of persistent regurgitation along with supra-esophageal manifestations such as burning throat, asthma, chronic cough, or hoarseness. Patients will be screened by Reflux Symptom Index \> 13. * Barrett's esophagus patients will be recruited based on histological diagnosis from previous endoscopic biopsy that will be found using the clinical database warehouse. Exclusion Criteria: * Age \<18 or \>85 * Active alcohol or drug abuse * History of ear, nose, throat and pulmonary diseases suspected of being GERD induced * History of head and neck malignancy and chemo-radiation therapy to the head and neck * Unable to give consent * Pregnant women (see justification in the Women and Minority Inclusion in Clinical Research section) * History of allergy to Lidocaine for nasal topical anesthesia * Allergy to green food dye * Asthma patients with an acute asthma exacerbation with symptoms including breathlessness, wheezing, and chest tightness
Where this trial is running
Milwaukee, Wisconsin
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Reza Shaker, MD — Medical College of Wisconsin
- Study coordinator: Reza Shaker, MD
- Email: rshaker@mcw.edu
- Phone: 4149556840
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.