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Recruiting
NCT05696184
Mechanisms Preventing Pharyngeal Reflux
Conditions: GERD
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 300
Sponsor: Medical College of Wisconsin
Location: United States
Summary
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.
Eligibility Criteria
Inclusion Criteria:Age 18 to 85GERD patients with complaints of regurgitation and supra-esophageal symptoms will be included and recruited from our GI & Otolaryngology clinicsGERD patients without complaint of supra-esophageal symptoms and regurgitation will be included and recruited from our GI & Otolaryngology clinicsAsthma 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 >85Active alcohol or drug abuseHistory of ear, nose, throat and pulmonary diseases suspected of being GERD inducedHistory of head and neck malignancy and chemo-radiation therapy to the head and neckUnable to give consentPregnant women (see justification in the Women and Minority Inclusion in Clinical Research section)History of allergy to Lidocaine for nasal topical anesthesiaAllergy to green food dyeAsthma patients with an acute asthma exacerbation with symptoms including breathlessness, wheezing, and chest tightness
Source: ClinicalTrials.gov (NCT05696184). StuddyBuddy aggregates publicly available trial information.