Functional Dyspepsia Clinical Trial
Official title:
The Relationship Between Gastric Accommodation, Transient Lower Esophageal Sphincter Relaxations and Reflux Events in Healthy Subjects and in Gastro-esophageal Reflux Disease Patients With or Without Overlapping Dyspepsia
NCT number | NCT03788109 |
Other study ID # | S57615 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 12, 2018 |
Est. completion date | June 15, 2018 |
Verified date | December 2019 |
Source | Universitaire Ziekenhuizen Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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). Ingestion of a meal was accompanied by a drop in IGP, probably representing gastric accommodation (GA). However, the magnitude of this IGP drop varied, and was inversely correlated with the number of transient lower esophageal sphincter relaxations (TLESRs) and the number of reflux events, both in patients and in HV: a smaller meal-induced drop in IGP was associated with a higher rate of reflux events, and vice versa. These findings suggest that impaired GA is a trigger for reflux. Furthermore, impaired GA is a well-established mechanism underlying symptom generation in functional dyspepsia (FD). Hence, the investigators hypothesize that impaired GA is an important pathophysiological feature explaining the overlap between GERD and FD. To evaluate this hypothesis, the investigators will study the relationship between GA, TLESRs and reflux events in HV and in a group of GERD patients which will be categorized as pure GERD or GERD/FD overlap.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 15, 2018 |
Est. primary completion date | June 15, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven Campus Gasthuisberg O&N1 | Leuven | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in number transient lower esophageal sphincter relaxations | Change in number TLESRs between preprandial and postprandial period | 6-hour study period | |
Secondary | Change in number of reflux episodes | Change in number of reflux episodes between preprandial and postprandial period | 6 hour study period | |
Secondary | Change in intragastric pressure | Change in intragastric pressure between preprandial and postprandial period | 6 hour study period |
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