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临床试验/NCT00534443
NCT00534443已完成4 期

A Clinical Study of the Efficacy of Esomeprazole or Rabeprazole on the Pattern of Release of Pro- and Anti-inflammatory Cytokines From Gastric Mucosa of Patients With Peptic Ulcer Disease

University of Athens2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2007年2月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
150
试验地点
2
主要终点
Effect of treatment on changes of cytokines levels in serum of patients

研究概览

简要总结

Although all PPIs are effective, there are some differences in their clinical performance, particularly in terms of the degree and speed of gastric acid suppression. Few data are also available about their effect of the pathophysiological mechanisms of gastritis and peptic ulcer disease. Aim of the present study is to investigate the effect of therapy with esomeprazole or rabeprazole on the mechanism of pathogenesis of gastritis and particularly on the pattern of release of pro- and anti- inflammatory cytokines associated to peptic ulcerative process by the gastric mucosa.

详细描述

Although all PPIs are effective, there are some differences in their clinical performance, particularly in terms of the degree and speed of gastric acid suppression. Few data are also available about their effect of the pathophysiological mechanisms of gastritis and peptic ulcer disease.

Triggering receptor expressed on myeloid cells (TREM)-1 is a recently discovered receptor expressed on the surface of neutrophils and monocytes. Engagement of TREM-1 has been reported to trigger the synthesis of proinflammatory cytokines. A soluble form of TREM-1, named sTREM-1, was observed and identified at significant levels in serum samples from patients with disease of the gastrointestinal tract inflammatory bowel disease. rendering interest about the implication of sTREM-1 in their pathogenesis.

sTREM-1 was also found elevated in the gastric juice of patients with peptic ulcer disease being correlated to the degree of the infiltration of the gastric mucosa by neutrophils.

Published data of our group elicit that sTREM-1 secretion is a crucial parameter for evolution from chronic gastritis to peptic ulcer disease. Samples of biopsies of gastric mucosa were cultured in the absence/presence of endotoxins showing that the inflamed mucosa was a potent secretor of sTREM-1 whatever ceased to exist post-antisecretory treatment.

Aim of the present study is to investigate the effect of therapy with esomeprazole or rabeprazole on the mechanism of pathogenesis of gastritis and particularly on the pattern of release of pro- and anti- inflammatory cytokines associated to peptic ulcerative process by the gastric mucosa.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Written informed consent.
  • Abdominal pain or discomfort and/or
  • Epigastric pain with nausea and vomiting and/or
  • Dyspepsia.

排除标准

  • Recent upper GI bleeding
  • Gastric carcinoma
  • Diabetes mellitus
  • Liver cirrhosis
  • Acute or chronic renal failure
  • The ingestion of any antimicrobial or antisecretory medication for at least 15 days prior to endoscopy.

结局指标

主要结局

Effect of treatment on changes of cytokines levels in serum of patients

时间窗: Baseline and 8 weeks

次要结局

  • Effect of treatment on changes of cytokines levels in supernatants of cultures of gastric mucosa(Baseline and 8 weeks)

研究者

发起方
University of Athens
申办方类型
Other

研究点 (2)

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