DRKS00012534进行中（未招募）未知
Effect of a probiotic combination on anti-Helicobacter pylori treatment related adverse effects in children - a multicenter double blind RCT - HeliP Study
Klinikum der Universität München, Campus Innenstadt0 个研究点目标入组 33 人开始时间: 2017年6月27日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 5 Years 至 18 Years（—）
- 性别
- All
入选标准
- •(a) Male or female patients aged between 5 - 18 years.
- •(b) Minimal body weight of 15 kg.
- •(c) H. pylori infection confirmed by positive culture and results of susceptibility testing for clarithromycin and metronidazole.
- •(d) No previous therapy for H. pylori infection.
- •(e) Screening diary completed with = 6/7 days.
- •(f) Written informed consent by parents/care giver and patients (6-11 years and 12-17 years).
排除标准
- •(a) Significant acute or chronic gastrointestinal or other disease interfering with assessment of symptoms.
- •(b) Known allergies to used antibiotics, proton pump inhibitors or probiotics.
- •(c) Having received treatment with antibiotics or bismuth compounds during the previous 30 days.
- •(d) Having received proton pump inhibitors during the previous two weeks.
- •(e) Having received probiotic therapy during the previous 14 days.
- •(f) Being infected with a strain resistant to clarithromycin and metronidazole (double resistant).
- •(g) Severe acquired or primary immunodeficiency.
- •(h) Diarrhea as defined in the study protocol for at least 2 days documented on the screening diary.
研究者
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