Twice-a-day PPI, Tetracycline, Metronidazolequadruple Therapy With Pylera® or Lactobacillus Reuteri for Treatment naïve or for Retreatment of H. Pylori: Two Randomized Pilot Studies
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Helicobacter pylori eradication rate
研究概览
简要总结
This study investigates the efficacy of a b.i.d. quadruple therapy containing Pylera® or L. reuteri for H. pylori infection.
详细描述
Bismuth, metronidazole and tetracycline yielded high cure rates for H. pylori infection. Earlier studies suggested that the bismuth quadruple therapy may be effective when given twice-a-day rather than q.i.d. and that b.i.d. therapy was associated with fewer side effects. The addition of the probiotic Lactobacillus reuteri (Gastrus®) to Lactobacillus reuteri (Gastrus®) that has been shown to increase the cure rates by 10-14%. In another study bismuth supplementation with L. reuteri DSM 17938, in a modified low dose quadruple therapy provided good eradication rates (93.3%; 95% CI : 85-99%) in clinical practice.
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
- 否
入选标准
- •Positive for H. pylori infection
排除标准
- •Presence of malignancy
- •Pregnancy or lactation
- •Clinically significant diseases
- •History of drug or alcohol abuse
- •Allergy to pantoprazole or to any component of regimens used in the study
- •Use of anti-secretory drugs, antibiotics or probiotics 4 weeks preceding the enrollment.
研究组 & 干预措施
B.I.D. TMPPI + Lactobacillus-10
pantoprazole 20 mg, tetracycline 500 mg, and metronidazole 500 mg twice a day supplemented with 1 capsule (2 x 108 CFU of L. reuteri DSM 17938 plus 2 x 108 CFU of L. reuteri ATCC PTA 6475) a day in the afternoon, given with the midday and evening meals for 10 days
干预措施: Bismuth Subcitrate Potassium (Drug)
B.I.D. Bismuth
pantoprazole 20 mg and the same doses of antibiotics administered as tetracycline 250 mg, and metronidazole 250 mg plus 1 cp (140 mg bismuth subcitrate potassium, 125 mg metronidazole, and 125 mg tetracycline hydrochloride administered) x 2 all drugs twice-a-day given with the midday and evening meals for 10 days
干预措施: Gastrus (Dietary Supplement)
结局指标
主要结局
Helicobacter pylori eradication rate
时间窗: 30-40 days after the end of treatment
a negative 13C-urea breath test and/or a negative stool antigen test
次要结局
- Compliance and side effects evaluation(30-40 days)
研究者
Maria Pina Dore
Professor
Università degli Studi di Sassari