Esomeprazole Treatment for Patients With Lymphocytic Gastritis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether treatment with esomeprazole alone is able to heal patients with lymphocytic gastritis

Detailed Description
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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.

Official Title
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Double-Blind, Randomized, Placebo-Controlled Multicenter Trial on the Efficacy of Esomeprazole Treatment for Patients With Lymphocytic Gastritis

Conditions
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Lymphocytic Gastritis

Intervention / Treatment
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* Drug: Esomeprazole


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Esomeprazole|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  |