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Mechanisms Preventing Pharyngeal Reflux

Medical College of Wisconsin · NCT05696184

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–85 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
300
US sites recruiting
1
Study start
November 1, 2013
Record last updated
February 10, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy; Slow and rapid intra-esophageal infusion

Conditions: GERD

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Medical College of Wisconsin

    Milwaukee, WI 53086

    Site contact: Reza Shaker, MD · 4149556840 · rshaker@mcw.edu

Study contacts (from the official record)

  • Reza Shaker, MD · 4149556840 · rshaker@mcw.edu
  • Mark Kern · 4148053826 · mkern@mcw.edu
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Mechanisms Preventing Pharyngeal Reflux (NCT05696184) | Bored Studies