Double-blind, Placebo-controlled, Randomized Study for Assesment of the Efficiency and Safety Quadruple Therapy for Helicobacter Pylori Infection With or Without the Addition of Saccharomyces Boulardi Probiotic
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 主要终点
- Result of urea breath test (Eradication of H.pylori)
研究概览
简要总结
This study assesses the effect of quadruple therapy for H. pylori, with the addition of probiotics Saccharomyces boulardii. In addition, he assesses whether this combination reduces the frequency of adverse effects of eradication therapy, and whether it affects the compliance.
详细描述
Standard triple therapy for H. pylori infection proved to be insufficiently effective, primarily due to antibiotics resistance.Therefore, the latest Maastricht consensus suggests using bismuth-quadruple or non-bismuth-quadruple therapy, in regions with high clarithromycin resistance. The addition of probiotics with eradication therapy has never become a standard treatment. However, the Maastricht consensus suggest that the addition of probiotics could increase the effectiveness of quadruple therapy.
The study was designed as a prospective, double-blind, randomized, case-control intervention study.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dyspepsia
- •Patients not treated for H. Pylori
- •Age of 18-50 years
- •Positive urea breath test
排除标准
- •Alarm symptoms (anemia, persistent vomiting, hematemesis, dysphagia, significant weight loss, palpable mass in abdomen)
- •Gastric cancer
- •Immunosuppressive therapy
- •Use of acetylsalicylic acid
- •Severe renal failure
- •Severe liver failure
- •Immunodeficiency
- •Proven malignant disease
- •Penicillin allergy
- •Allergy to any component of dietary supplement (Saccharomyces boulardii and Vitamin D)
- •Chronic alcoholism
- •Pregnancy
- •Lactation
研究组 & 干预措施
S.boulardi
Quadruple eradication therapy with S. boulardi
干预措施: Saccharomyces boulardii (Drug)
Placebo
Quadruple eradication therapy without S. boulardi
干预措施: Placebo (Drug)
结局指标
主要结局
Result of urea breath test (Eradication of H.pylori)
时间窗: baseline to 8 weeks after the introduction of the therapy
Test remains positive (Eradication of H.pylori unsuccessful) or test becomes negative (eradication of H.pylori successful)
次要结局
- Side effects of eradication therapy(baseline to 8 weeks after the introduction of the therapy)
- Compliance of eradication therapy(baseline to 8 weeks after the introduction of the therapy)
研究者
Miodrag Krstic
Clinical Professor
Clinical Centre of Serbia