NCT05696184 · Medical College of Wisconsin
Mechanisms Preventing Pharyngeal Reflux
What this 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Milwaukee, Wisconsin
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 10, 2026 · Source of record for eligibility and locations