RECRUITING

Mechanisms Preventing Pharyngeal Reflux

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Pathophysiology of Pharyngo-esophageal Junction and Esophageal Mechanisms Preventing Pharyngeal Reflux of Gastric Content

Quick Facts

Study Start:2013-11-01

Study Completion:2024-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05696184

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Reza Shaker, MD

CONTACT

4149556840

rshaker@mcw.edu

Mark Kern

CONTACT

4148053826

mkern@mcw.edu

Principal Investigator

Reza Shaker, MD

PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Study Locations (Sites)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53086

United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

Reza Shaker, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-11-01

Study Completion Date2024-06-30

Study Record Updates

Study Start Date2013-11-01

Study Completion Date2024-06-30

Terms related to this study

Additional Relevant MeSH Terms

GERD