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临床试验/NCT02018328
NCT02018328Unknown不适用

The Impact of Addition of Curcumin for 10 Days Triple Therapy, on the Eradication Rate of Helicobacter Pylori Infection

Gingold Belfer Rachel2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
2
主要终点
Urea breath test

研究概览

简要总结

Background and Aims

  • H.pylori is a common human pathogen by which almost 50% of the world population is infected. According to the accepted guidelines, once H.pylori infection has been diagnosed,first line therapy with three drugs should be given. The triple treatment includes proton-pump-inhibitor-clarithromycin-amoxicillin but its eradication rate is only 70-80%.
  • Curcumin has many beneficial merits and it was also been demonstrated to be efficient in inhibition of H.pylori infection, in vitro.Therefore we aim to investigate whether addition of Curcumin to the standard triple therapy will increase the eradication rate of H.pylori infection.

Methods

  • 150 consecutive patients that will undergo esophagogastroscopy in our Gastroenterology department and will be positive for H.pylori according to urease test and then by gastric biopsy, will be included. The patients will be randomized to two different treatments, according to binomial distribution. 75 patients will be treated with the standard triple therapy for 10 days and the other 75, will be treated for 10 days, with triple therapy combined with Curcumin that will be given three times a day.
  • During the treatment the patients will complete an adverse effect's questionnaires. 6 weeks after the completion of the treatment the patients will undergo urea breath test to confirm eradication. Patients will be asked to avoid antibiotics, bismuth compounds or proton-pump-inhibitor until the second urea-breath-test.
  • We will compare the eradication rate and the adverse effects between the two groups by using SPSS

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
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
是

入选标准

  • •positivity for Helicobacter pylori by urease test and gastric biopsy

排除标准

  • •prior treatment for H. pylori
  • •allergy to penicillin
  • •gastric outlet obstruction
  • •pregnancy or breast feeding
  • •inability to understand the informed consent

研究组 & 干预措施

Triple therapy, helicobacter pylori

No Intervention

triple therapy+curcumin helicobacter pylori

Experimental

Curcumin will be added to the regular triple therapy

干预措施: Curcumin (Dietary Supplement)

结局指标

主要结局

Urea breath test

时间窗: 6 weeks after the completion of the treatment

次要结局

未报告次要终点

研究者

发起方
Gingold Belfer Rachel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gingold Belfer Rachel

MD

Rabin Medical Center

研究点 (2)

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