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临床试验/NCT04550858
NCT04550858Unknown不适用

Effect of Treatment With REbamipide for Helicobacter Pylori Eradication Therapy

Assiut University0 个研究点目标入组 60 人开始时间: 2020年9月5日最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
60
主要终点
Gastric ulcer healing rate in resistant cases of H. pylori resistant cases of h.pylori

研究概览

简要总结

the primary aim is specially in resistant cases of H.pylori and in promotion of peptic ulcer

详细描述

Helicobacter pylori infection is the main cause of peptic ulcer (1, 2) Some consensus conferences have recommended triple therapy with a proton pump inhibitor (PPI) and two types of antibiotics for 7 days as first-line treatment when patients with peptic ulcer have Helicobacter pylori infection.(3, 4)This recommendation is based on the finding that patients with proven eradication of H. pylori have an extremely low rate of recurrence of peptic ulcer.(5) Although a well-controlled study found comparable rates of small gastric ulcer healing after eradication therapy alone without continuation of antiulcer treatment, relief of symptoms was significantly slower with eradication therapy alone. Moreover, the success rate of eradication therapy has decreased during the past few decades, and whether or not eradication is successful becomes clear only 2-4 weeks after treatment(6).

Patients with large gastric ulcer lesions are often not completely healed with H. pylori eradication alone (7) . Proton pump inhibitors (PPIs) have become the mainstay of maintenance therapy after eradication of H. pylori infection due to the associated effective healing and fast relief of symptoms without tachyphylaxis. However, PPI therapy has some risks, including dyspeptic symptom or rebound acid hypersecretion after cessation that may induce dependence (8,9) , drug interactions with other substrate of CYP2C19, and some kinds of respiratory or gastrointestinal infections . Also, the result of H. pylori eradication can be affected by such antisecretory drugs.(10) Rebamipide is a gastroprotective antiulcer drug that has been found to reduce the rate of recurrence of gastric ulcers without affecting H. pylori status, unlike antisecretory drugs such as PPIs and H2 receptor antagonists.6 and have a healing rate of about 90% at 8 weeks after eradication therapy (11) Rebamipide (2-(4- chlorobenzoylamino)-3-[2-(1H)-quinolinon-4-yl] propionic acid) prevents gastric ulcer formation by inhibiting neutrophil activation. Rebamipide stimulates prostaglandin generation in the gastric mucosa, resulting in stimulation of mucus secretion. Rebamipide inhibits H. pylori adhesion to the gastric epithelial cells.(12) The primary aim of study to evaluate whether rebamipide could improve success rates of anti-H. pylori treatment .

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 20 years of age or older,
  • ulcer size, 5 mm or more in longest diameter,
  • single ulcer,
  • H. pylori positively.

排除标准

  • use of medications such as PPIs, H2-receptor antagonists, other gastroprotective drugs, or nonsteroidal anti-inflammatory drugs within a week prior to the start of the trial, (2) previous eradication therapy for H. pylori, (3) acute or duodenal ulcer, (4) gastric ulcer with high risk of massive bleeding

结局指标

主要结局

Gastric ulcer healing rate in resistant cases of H. pylori resistant cases of h.pylori

时间窗: 8 weeks

healing rate of gastric ulcer defined as complete disappearance of the white coating

次要结局

  • Eradication of H. pylori(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marwa Ahmed Mohamed Abdelrahman

director

Assiut University

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