A Prospective, Observational Study of the PPI Non-responder
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|ClinicalTrials.gov Identifier: NCT03282084|
Recruitment Status : Withdrawn (insufficient funding)
First Posted : September 13, 2017
Last Update Posted : April 2, 2019
|Condition or disease||Intervention/treatment|
|Gastro Esophageal Reflux Disease PPI Non-Responders||Diagnostic Test: EGD with biopsy Diagnostic Test: EGD and impedance-pH study on PPI|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||A Prospective, Observational Study of the PPI Non-responder|
|Actual Study Start Date :||June 20, 2017|
|Actual Primary Completion Date :||June 15, 2018|
|Actual Study Completion Date :||June 15, 2018|
Subjects with no prior testing, normal prior EGD or prior LA Grade A esophagitis
Diagnostic Test: EGD with biopsy
Stop PPI and schedule for EGD with biopsy and Wireless pH capsule testing for 7-10 days later. Consider gastric emptying scan or high resolution esophageal manometry
Other Name: Wireless pH Capsule
LA Grade B-D esophagitis, long-segment Barrett's, prior positive pH study
Diagnostic Test: EGD and impedance-pH study on PPI
Continue PPI and schedule EGD and Impedance-pH study on PPI. Consider gastric emptying scan or high resolution esophageal manometry
- Objectively evaluate PPI non-responder [ Time Frame: 8 Weeks after visit 2 ]Number of participants with unproven GERD who have reflux esophagitis and eosinophile esophagitis
- Esophageal acid exposure [ Time Frame: 8 Weeks after visit 2 ]Number and extent of abnormal acid exposure as measured by pH-metry (Bravo capsule) off PPI.
- Response to different PPI [ Time Frame: 8 Weeks after visit 2 ]Percentage of patients with GERD who fail standard PPI Therapy as documented by wireless pH capsule testing that then respond to an alternative PPI
- Document the amount of esophageal acid and non-acid exposure in the PPI non-responder patient with proven GERD [ Time Frame: 8 Weeks after visit 2 ]Amount of acid and non-acid exposure in PPI-nonresponder patients with proven GERD as measured by impedance-pH testing on daily PPI therapy.
- Determine the type, frequency and extent of esophageal motility disorders [ Time Frame: 8 Weeks after visit 2 ]Determine the type, frequency and extent of esophageal motility disorders using HREM (high resolution esophageal manometry) in patients with persistent GERD symptoms despite PPI therapy
- Nepean Dyspepsia Index [ Time Frame: 8 Weeks after visit 2 ]Using a validated questionnaire determine the prevalence and severity of functional dyspepsia in patients presenting with GERD symptoms using the Nepean Dyspepsia Index.
- Correlate subjective symptoms of GERD with objective evidence of acid reflux [ Time Frame: 8 Weeks after visit 2 ]Comparison of symptomatic GERD based on GERD-Q validated questionnaire and pH testing
- Assess overlapping symptoms of dysphagia and GERD [ Time Frame: 8 Weeks after visit 2 ]Assess overlapping symptoms of dysphagia in patients with GERD symptoms who do not respond to empiric PPI therapy using a validated dysphagia questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282084
|Principal Investigator:||Brian E Lacy, MD, PhD||Dartmouth-Hitchcock Medical Center|