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临床试验/NCT03220542
NCT03220542Unknown4 期

The Effect of Broccoli Sprout Extract and Probiotics on Proton Pump Inhibitor-based Triple Therapy for Eradication of Helicobacter Pylori: a Prospective Randomized Trial

Kyunghee University Medical Center1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
360
试验地点
1
主要终点
Helicobacter pylori eradication

研究概览

简要总结

In Korea, the first-line therapy to treat Helicobacter pylori (Hp) consists of a proton pump inhibitor (PPI) and two antibiotics for one week. But, eradication has become less successful due to low compliance and high resistance to the antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. In vitro study, we previously reported that a broccoli sprout extract containing sulforaphane may prevent lipid peroxidation in the gastric mucosa and play a cytoprotective role in Hp-induced gastritis. Also, several studies suggested that probiotics could be effective for improving Hp eradication rate or reducing adverse events. But, their effect for eradication of Hp is not yet conclusive. The aims of this prospective study is to investigate the efficacy of a broccoli sprout extract containing sulforaphane and probiotics for eradication of Hp, compared with standard triple therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Helicobacter pylori infected patients
  • Patients with active or healing gastric/duodenal ulcers

排除标准

  • prior Hp eradication therapy
  • previous gastric resection
  • previous use of proton pump inhibitors, bismuth, H2 receptor antagonist or antibiotics within 4 weeks of the study
  • Patients who were pregnant or lactating

研究组 & 干预措施

Triple Therapy

Active Comparator

Esomeprazole + Amoxicillin + Clarithromycin

干预措施: Esomeprazole (Drug)

Probiotics

Experimental

Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin

干预措施: Probiotics (Drug)

Probiotics

Experimental

Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin

干预措施: Esomeprazole (Drug)

Probiotics

Experimental

Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin

干预措施: Amoxicillin (Drug)

Probiotics

Experimental

Saccharomyces boulardii + Esomeprazole + Amoxicillin + Clarithromycin

干预措施: Clarithromycin (Drug)

Broccoli

Experimental

Broccoli Sprouts Extract + Esomeprazole + Amoxicillin + Clarithromycin

干预措施: Broccoli (Dietary Supplement)

Broccoli

Experimental

Broccoli Sprouts Extract + Esomeprazole + Amoxicillin + Clarithromycin

干预措施: Esomeprazole (Drug)

Broccoli

Experimental

Broccoli Sprouts Extract + Esomeprazole + Amoxicillin + Clarithromycin

干预措施: Amoxicillin (Drug)

Broccoli

Experimental

Broccoli Sprouts Extract + Esomeprazole + Amoxicillin + Clarithromycin

干预措施: Clarithromycin (Drug)

Triple Therapy

Active Comparator

Esomeprazole + Amoxicillin + Clarithromycin

干预措施: Amoxicillin (Drug)

Triple Therapy

Active Comparator

Esomeprazole + Amoxicillin + Clarithromycin

干预措施: Clarithromycin (Drug)

结局指标

主要结局

Helicobacter pylori eradication

时间窗: 5 weeks after treatment initiation

Using the urea breath test

次要结局

未报告次要终点

研究者

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

Jung-Wook Kim

Clinical assistant professor

Kyunghee University Medical Center

研究点 (1)

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