Back to search results

Understanding Mechanisms Preventing Pharyngeal Reflux in GERD Patients

This study aims to understand how your body prevents stomach acid from reaching your throat (pharyngeal reflux), especially if you have GERD (Gastroesophageal Reflux Disease). Researchers will use a combination of diagnostic tests: concurrent manometry/impedance/pH with video pharyngo-laryngoscopy and slow and rapid intra-esophageal infusion. These tests help measure pressure and acid levels in your esophagus and throat, and observe how your body responds to simulated reflux. The study is looking for 300 participants, including those with GERD (with or without throat symptoms) and asthma patients. The goal is to identify differences in how the upper esophageal sphincter (the muscle at the top of your esophagus) and surrounding areas protect against reflux. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 300 participants. It will involve diagnostic tests to understand the body's response to simulated reflux.
What's involved
You would undergo diagnostic tests including combined manometric/impedance/pH recording and intra-esophageal infusions. The record does not specify the duration or number of visits.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, Pressure Data Analysis and Videoendoscopic data analysis, are measured during simulated reflux perfusion of the esophagus. The record does not specify follow-up after this period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05696184

Mechanisms Preventing Pharyngeal Reflux

Recruiting
NAAges 18–85InterventionalDiagnostic
Medical College of Wisconsin
~300 participants
Updated 2026-02-10 on ClinicalTrials.gov
What's tested:Concurrent manometry/impedance/pH with video pharyngo-laryngoscopySlow and rapid intra-esophageal infusion

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pressure Data Analysis
Measured over During simulated reflux perfusion of the esophagus
+1 more outcome measured

Conditions

GERD

Explore related trials

AsthmaBarrett EsophagusGastroesophageal Reflux Disease

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Reza Shaker, MD · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin

Who to contact

Reza Shaker, MD
[email protected]
4149556840
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Pressure Data AnalysisDuring simulated reflux perfusion of the esophagus

    All pressure measurements will be recorded at a 35HZ frequency and measured in reference to the atmospheric pressure UES and LES pressures will be measured utilizing the e-sleeve function of the manometric analysis software. All UES, LES and esophageal baseline pressures will be measured as peaks and troughs over 3 tidal volume respiratory cycles at stable resting conditions when no pharyngeal, gastric, esophageal, UES or LES events are present. Type, frequency, amplitude, onset, and duration of the UES response along with the LES and esophageal body response will be recorded.

  • Videoendoscopic data analysisDuring simulated reflux perfusion of the esophagus

    Onset of the entry of colored refluxate into the pharynx though the UES inlet will be determined and correlated with the UES, esophageal and LES pressure phenomena, impedance and pH events. Endoscopic documentation of pharyngeal reflux will be considered the gold standard and impedance and pH data will be compared to it.