Status:
COMPLETED
Relationship Between Gastric Accommodation, TLESRs and Reflux in HV and in GERD With or Without Overlapping Dyspepsia
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Gastro-esophageal Reflux Disease
Functional Dyspepsia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Our group recently studied the relationship between intra-gastric pressure (IGP) and reflux events after a meal, both in gastro-esophageal reflux disease (GERD) and in healthy volunteers (HV). Ingesti...
Detailed Description
1. INTRODUCTION Gastro-esophageal reflux (GER), the retrograde flow of gastric contents in the esophagus, is a physiologic phenomenon. However, when GER causes symptoms (heartburn/regurgitation) or le...
Eligibility Criteria
Inclusion
- GERD patients:
- typical symptoms of reflux, such as heartburn and/or regurgitation;
- gastro-esophageal reflux assessed by 24-h pH-impedance monitoring or a positive symptom association or;
- esophagitis assessed by upper GI endoscopy with careful evaluation of the presence and extent of a hiatal hernia (HH).
- GERD/FD overlap:
- FD symptoms according to the Rome III criteria. The symptoms of FD include one or more of: bothersome postprandial fullness occurring after normal sized meals, early satiation that prevents finishing a regular meal, epigastric pain, and epigastric burning at least several times per week during the last 6 months.
Exclusion
- Healthy volunteers:
- history of any upper gastrointestinal (GI) symptoms or GI surgery;
- psychological disorders;
- any drug history;
- use of medication altering GI motility;
- pregnant or nursing women.
- GERD patients:
- psychological disorders;
- any drug history;
- use of medication affecting GI motility;
- pregnant or nursing women;
- history of GI surgery.
Key Trial Info
Start Date :
June 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03788109
Start Date
June 12 2018
End Date
June 15 2018
Last Update
December 6 2019
Active Locations (1)
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1
Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven Campus Gasthuisberg O&N1
Leuven, Vlaams-Brabant, Belgium, 3000