NCT05696184 Mechanisms Preventing Pharyngeal Reflux
| NCT ID | NCT05696184 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical College of Wisconsin |
| Condition | GERD |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2013-11-01 |
| Primary Completion | 2026-10-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2013-11-01 with a primary completion date of 2026-10-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Reza Shaker, MD
PRINCIPAL INVESTIGATOR
Medical College of Wisconsin
Frequently Asked Questions
Who can join the NCT05696184 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying GERD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05696184 currently recruiting?
Yes, NCT05696184 is actively recruiting participants. Contact the research team at rshaker@mcw.edu for enrollment information.
Where is the NCT05696184 trial being conducted?
This trial is being conducted at Milwaukee, United States.
Who is sponsoring the NCT05696184 clinical trial?
NCT05696184 is sponsored by Medical College of Wisconsin. The principal investigator is Reza Shaker, MD at Medical College of Wisconsin. The trial plans to enroll 300 participants.