Clinical Trial: Esomeprazole Treatment for Patients With Lymphocytic Gastritis
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Double-Blind, Randomized, Placebo-Controlled Multicenter Trial on the Efficacy of Esomeprazole Treatment for Patients With Lymphocytic Gastritis
Brief Summary: The purpose of this study is to determine whether treatment with esomeprazole alone is able to heal patients with lymphocytic gastritis
Detailed Summary: 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.
Sponsor: Technische Universität Dresden
Current Primary Outcome:
- 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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
Original Secondary Outcome: Same as current
Information By: Technische Universität Dresden
Dates:
Date Received: April 3, 2007
Date Started: February 2007
Date Completion: December 2009
Last Updated: April 3, 2007
Last Verified: February 2007