Double-Blind, Randomized, Placebo-Controlled Multicenter Trial on the Efficacy of Esomeprazole Treatment for Patients With Lymphocytic Gastritis
试验速览
- 阶段
- 3 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The primary objective is to assess the healing rate of
研究概览
简要总结
The purpose of this study is to determine whether treatment with esomeprazole alone is able to heal patients with lymphocytic gastritis
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven lymphocytic gastritis (IEL > 25/100)
- •Male or female aged 18 years or older
- •Signed and written informed consent
排除标准
- •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)
结局指标
主要结局
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.
次要结局
- 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