Mechanisms Preventing Pharyngeal Reflux
RecruitingHealthy volunteers welcome
Pathophysiology of Pharyngo-esophageal Junction and Esophageal Mechanisms Preventing Pharyngeal Reflux of Gastric Content
Who can join
Ages 18 to 85 · All sexes · Healthy volunteers welcome
Full eligibility 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
About the study
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.
What is being tested
- Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy (diagnostic test)
- Slow and rapid intra-esophageal infusion (diagnostic test)
Sponsor: Medical College of Wisconsin · Participants: 300 · Started: Nov 1, 2013
Contact the study team
- Reza Shaker, MD · Phone: 4149556840
- Mark Kern · Phone: 4148053826
Official record on ClinicalTrials.gov — NCT05696184
Locations in the U.S.
| Wisconsin | Medical College of Wisconsin, Milwaukee |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.