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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group - Healthy Subjects | Active Comparator | Healthy volunteers with normal EGD. |
|
| NERD Group | Active Comparator | Subjects with NERD. Heartburn symp x2 wk for 3 months. Normal EGD and abnormal 24 hour pH. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 24-Hr Esohpageal pH Monitoring | Procedure | 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. |
| 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. |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcia Willis, CCRC | Contact | 520-792-1450 | 2032 | marcia.willis@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Ronnie Fass, MD | Southern Arizona Veterans Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Arizona VA Health Care System | Recruiting | Tucson | Arizona | 85723 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 17, 2011 | |
| Reset | Apr 12, 2011 | |
| Release | Apr 13, 2011 | |
| Reset | May 6, 2011 | |
| Release | May 11, 2011 | |
| Reset | Jun 9, 2011 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 17, 2011 | Apr 12, 2011 | |||
| Apr 13, 2011 |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| PCO2 Acid Perfusion and 0.1N HCI Perfusion | Procedure | 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. |
|
| Southern Arizona Veterans Health Care System | Recruiting | Tucson | Arizona | 85723 | United States |
|
| May 6, 2011 |
| May 11, 2011 | Jun 9, 2011 |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |