The Effect of High PCO2 Solution on Esophageal Acid Sensation

Study Overview
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Brief Summary
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To determine the effect of intraesophageal high PCO2 solution as compared to acidic and saline solutions on subjects' heartburn sensation using stiumlus-response functions.

Detailed Description
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Presently, the exact mechanism of GERD and the role of CO2 in pathogenesis of heartburn symptoms is unclear. CO2 conversion to protons may play a key role in the mechanism for heartburn sensation. This is a prospective, randomized study that will help further explore the mechanism for heartburn sensation in GERD patients and can be a prelude for further studies examining the role of new class antireflux agents such as carbonic anhydrase inhibitors in the treatment of patients with heartburn.

Official Title
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The Effect of High PCO2 Solution on Esophageal Acid Sensation in Healthy Patients Versus Those With Non-Erosive Reflux Disease.

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Procedure: 24-Hr Esohpageal pH Monitoring
* Procedure: PCO2 Acid Perfusion and 0.1N HCI Perfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 10 Healthy Controls Normal EGD, Normal 24-hr pH 18-80 Years of age Able to read, understand and complete study questionnaires and diary Able to understand study procedures and sign informed consent Albe to comply with all study requirements 10 NERD (Non-Erosive Reflux Disease) 18-80 Years of age Willing to stop PPI/H2 Blocker prior to EGD Have heartburn symptoms 2+ times per week for at least 3 months. Exclusion Criteria: Esophageal erosions, Barretts, or peptic stricture on EGD Previous esophageal, gastric or duodenal surgery underlying co-morbidities Diabetes mellitus (requires insulin), scleroderms, or neuromuscular disorder Upper airway symptoms Tricyclic antidepressants, antispasmodics, selective serotonin receptor inhibitors, thiazides, bile acid-binding agents or prokinetics Patients who cannot or are unwilling to sign ICF

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group - Healthy Subjects<br>Healthy volunteers with normal EGD. | Procedure: PCO2 Acid Perfusion and 0.1N HCI Perfusion<br>* A small tube will be inserted through the nostril and into the esophagus. A mild CO2 solution or a mild saline solution will be administered for aprox. 10 minutes during which you will be asked questions regarding any symptoms you may experience.<br>|
| Active Comparator: NERD Group<br>Subjects with NERD. Heartburn symp x2 wk for 3 months. Normal EGD and abnormal 24 hour pH. | Procedure: 24-Hr Esohpageal pH Monitoring<br>* There will be a 24-hr pH monitoring procedure and two 10-minute infusions each one week apart consisting of high PCO2 solution and 0.1 N HCI solution.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Mechanism of GERD | Presently the exact mechanism of GERD and the role of CO2 in pathogenesis of heartburn sysmptoms is unclear. We aim to compare the effect of intraesophageal high PCO2 solution with saline solution on heartburn sensation. | NA There is no exact timeframe. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, Heartburn, Acid Reflux