Gastroesophageal Reflux Disease
Conditions
Keywords
GERD, Heartburn, Acid Reflux
Brief summary
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
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.
Interventions
PROCEDURE24-Hr Esohpageal pH Monitoring
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.
PROCEDUREPCO2 Acid Perfusion and 0.1N HCI Perfusion
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.
Sponsors
Southern Arizona VA Health Care System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Mechanism of GERD | NA There is no exact timeframe. | 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. |
Countries
United States
Contacts
Primary ContactMarcia Willis, CCRC
Outcome results
None listed