Understanding how to prevent pharyngeal reflux in GERD patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.