Esomeprazole Treatment for Patients With Lymphocytic Gastritis (LYNEX)

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

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

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.

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

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)