Lymphocytic Gastritis
Conditions
Brief summary
The purpose of this study is to determine whether treatment with esomeprazole alone is able to heal patients with lymphocytic gastritis
Detailed description
Recently, a placebo controlled trial of our group has shown that H. pylori eradication therapy consisting of omeprazole 20 mg bid, clarithromycin 500 mg bid, amoxicillin 1000 mg bid for seven days leads to a complete long-lasting resolution of lymphocytic gastritis in 96 % of patients. However, after 3 months we also found a healing rate of 50 % in patients who received omeprazole 20 mg bid and placebo antibiotics for seven days suggesting spontaneous remission or a potential PPI effect. Thus, we speculate that PPI therapy may have led to elimination of H. pylori and subsequently healing of lymphocytic gastritis in those patients with potentially minimal H. pylori colonization at baseline. For this reason we investigate whether a PPI treatment alone is able to heal patients with lymphocytic gastritis.
Interventions
DRUGEsomeprazole
Sponsors
Technische Universität Dresden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Histologically proven lymphocytic gastritis (IEL \> 25/100) * Male or female aged 18 years or older * Signed and written informed consent
Exclusion criteria
* Regular NSAID or aspirin intake * Concomitant medication with antibiotics, bismuth subsalicylate, aminosalicylates * Regular PPI therapy * Treatment with ketoconazole or other CYP3A inhibitors * previous surgery of the stomach * known or suspected hypersensitivity to esomeprazole * Malignant diseases * Concomitant severe diseases * Pregnancy or lactation * Contraindication to take biopsies (Quick \< 50%, PTT \> 50 s, thrombocytes \< 100.000/mm3)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to assess the healing rate of | — |
| patients with lymphocytic gastritis irrespective of H. pylori status after treatment | — |
| with esomeprazole 20 mg twice daily for 2 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective of the study are to evaluate the grade and activity of gastritis before and after | — |
| treatment according to updated Sydney classification, to assess the clinical GI symptoms at baseline and after 3 months | — |
| and to evaluate influence of the H. pylori-Status | — |
Countries
Germany
Contacts
Primary ContactAhmed Madisch, MD
Backup ContactStephan Miehlke, Prof., MD
Outcome results
None listed