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Esophageal Muscle Function Study for Acid Reflux
N/A
Recruiting
Led By Reza Shaker, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during simulated reflux perfusion of the esophagus
Awards & highlights
Study Summary
This trial aims to study how well the muscles in the food pipe work in people with documented reflux and heartburn.
Who is the study for?
This trial is for adults aged 18-85 with asthma of varying severity, GERD with or without supra-esophageal symptoms like chronic cough or hoarseness, and Barrett's esophagus confirmed by biopsy. Excluded are those under 18 or over 85, active substance abusers, certain ENT disease histories, pregnant women, Lidocaine allergy sufferers, green food dye allergies, and acute asthma exacerbation patients.Check my eligibility
What is being tested?
The study tests how well the upper esophageal sphincter works to prevent acid reflux into the throat. It involves slow and rapid infusions in the esophagus while monitoring pressure changes and pH levels alongside video imaging of the throat area.See study design
What are the potential side effects?
Potential side effects may include discomfort from nasal anesthesia with Lidocaine (for those not allergic), reactions to green food dye used in testing procedures if applicable, and general discomfort from endoscopic procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during simulated reflux perfusion of the esophagus
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during simulated reflux perfusion of the esophagus
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pressure Data Analysis
Videoendoscopic data analysis
Trial Design
5Treatment groups
Active Control
Group I: GERD patients with complaint of regurgitation and supra-esophageal reflux disease (SERD)Active Control2 Interventions
GERD patients with complaint of regurgitation and one of the following supra-esophageal symptoms attributed to reflux of gastric content: chronic cough, frequent throat clearing, history of non-deglutitive aspiration pneumonia, hoarse voice, chronic sinusitis and dental erosion i.e. SE-GERD. Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.
Group II: Asthma patients with and without supra-esophageal symptomsActive Control2 Interventions
Asthma patients with and without supra-esophageal symptoms (these symptoms include chronic cough, frequent throat clearing, history of non-deglutitive aspiration pneumonia, hoarse voice, chronic sinusitis, and dental erosion). Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.
Group III: Age and gender matched patient controls (GERD without regurgitation and supra-esophageal complaint)Active Control2 Interventions
Age and gender matched patient controls (GERD without regurgitation and supra-esophageal complaint). Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.
Group IV: Age and gender matched patient controls for diagnosed Barrett's esophagus patientsActive Control2 Interventions
Patient controls for diagnosed Barrett's esophagus patients. Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.
Group V: Age and gender matched healthy controlsActive Control2 Interventions
Controls will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.
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Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
610 Previous Clinical Trials
1,162,413 Total Patients Enrolled
Reza Shaker, MDPrincipal InvestigatorMedical College of Wisconsin
3 Previous Clinical Trials
329 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am younger than 18 or older than 85.I am unable to understand and give consent for treatment.I have asthma without a current severe flare-up.I have had ear, nose, throat, or lung issues thought to be caused by acid reflux.I have GERD with symptoms like heartburn and throat issues.I have had cancer in my head or neck and received combined chemotherapy and radiation.I am experiencing severe asthma symptoms like difficulty breathing, wheezing, and chest tightness.I have been diagnosed with gastroesophageal reflux disease.I am between 18 and 85 years old.I am on acid suppressive therapy for SERD and still experience severe regurgitation and throat symptoms.I have GERD and do not have symptoms above my esophagus.I have been diagnosed with Barrett's esophagus through a biopsy.
Research Study Groups:
This trial has the following groups:- Group 1: GERD patients with complaint of regurgitation and supra-esophageal reflux disease (SERD)
- Group 2: Asthma patients with and without supra-esophageal symptoms
- Group 3: Age and gender matched patient controls (GERD without regurgitation and supra-esophageal complaint)
- Group 4: Age and gender matched patient controls for diagnosed Barrett's esophagus patients
- Group 5: Age and gender matched healthy controls
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings for volunteers in this experimental research?
"The data on clinicaltrials.gov affirms that this study is currently recruiting patients, having been published in November 2013 and last revised on January 13th 2023."
Answered by AI
How many participants are engaged in this research endeavor?
"Affirmative. According to clinicaltrials.gov, this research study initiated on November 1st 2013 is still accepting volunteers. It has been modified most recently on 13th January 2023 and requires 300 participants from a solitary medical site."
Answered by AI
Is this experiment enrolling individuals who are 30 or over in age?
"This clinical trial has established a subject eligibility criterion of 18 to 85 years old. Additionally, there are 6 studies that accept individuals under the age of eighteen and 28 for people over 65."
Answered by AI
What criteria qualifies a person to take part in this scientific investigation?
"In this research endeavor, 300 participants who suffer from acid reflux and range in age from 18 to 85 are being recruited. In order to qualify for the trial, applicants must meet certain conditions such as experience GERD symptoms with or without regurgitation; have asthma that fall into intermittent, mild persistent, moderate persistent or severe persistent categories (as long as no exacerbation is present); have a Reflux Symptom Index higher than 13; and/or be diagnosed with Barrett's esophagus based on prior biopsy results according to American Gastroenterological Association & Montreal definition standards."
Answered by AI
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