The Effect of High PCO2 Solution on Esophageal Acid Sensation in Healthy Patients Versus Those With Non-Erosive Reflux Disease.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 20
- Locations
- 4
- Primary Endpoint
- The Mechanism of GERD
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
The Mechanism of GERD
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported