Esomeprazole Treatment for Patients With Lymphocytic Gastritis

Phase 3

• Conditions: Lymphocytic Gastritis

• Registration Number: NCT00455754
• Lead Sponsor: Technische Universität Dresden

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.

Study Timeline

• Status Verified: 2007-02
• Study Start: 2007-02
• Study First Submitted: 2007-04-03
• Study First Submitted QC: 2007-04-03
• Last Update Submitted: 2007-04-03
• Study First Posted: 2007-04-04
• Last Update Posted: 2007-04-04
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Medical Department I, University Hospital Carl Gustav Carus, Technical University; 🇩🇪 Dresden, Germany