Healthy
Conditions
Keywords
volunteers
Brief summary
The purpose of this study is to determine whether proton pump inhibitor (PPI) induced hypersecretion leads to acid related symptoms after treatment in healthy volunteers.
Detailed description
Treatment with proton pump inhibitors (PPI) has been shown to cause rebound hypersecretion of gastric acid. The clinical significance of this phenomenon is however unclear. This study aims to examine whether or not healthy volunteers, who over a relatively short period of time treated with a PPI, develop dyspeptic symptoms after cessation of therapy. Dyspeptic symptoms will be measured subjectively using a validated questionnaire, which is filled out each day. Gastric acid will be measured indirectly with measurement of acid secretion markers (Gastrin and chromogranin-A).
Interventions
DRUGPantoprazole
40 mg pantoprazole once daily for 28 days
DRUGPlacebo
identical placebo once daily for 28 days
Sponsors
Sahlgrenska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers * 18-70 years of age * Informed consent * No prior history of any GI disorder
Exclusion criteria
* Dyspeptic complaints * H. pylori infection * Ongoing treatment with pain-relieving medications (i.e., NSAID) * Pregnancy or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate whether healthy volunteers, treated with PPI for four weeks, develop acid-related symptoms after cessation of PPI therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate whether there is a correlation between markers for acid secretion such as gastrin and chromogranin-A and the development of dyspeptic symptoms. | — |
Countries
Sweden
Outcome results
None listed