Mechanisms Preventing Pharyngeal Reflux

Launched by MEDICAL COLLEGE OF WISCONSIN · Jan 13, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on understanding a condition called gastroesophageal reflux disease (GERD), specifically looking at how certain muscles in the throat may not work properly, leading to reflux symptoms. Researchers want to learn more about the problems that cause food or stomach acid to come back up into the throat, which can cause discomfort and other symptoms like a burning throat or asthma. The study will use a special method to detect reflux accurately.

If you are between 18 and 85 years old and have GERD symptoms like regurgitation or throat issues, you may be eligible to participate. Patients with asthma who also experience throat symptoms can also join the study. Participants will be recruited from clinics specializing in gastrointestinal and throat conditions. If you decide to join, you can expect to undergo some tests to help researchers gather information about your symptoms and how your body is responding. It’s important to note that certain people, like those with severe allergies or recent respiratory issues, may not be able to participate.

Gender

ALL

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