Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients: a Double Blind Placebo Controlled Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Eradication of H Pylori Infection 4 Weeks After Completion of Therapy
研究概览
简要总结
Addition of L. reuteri to the standard triple therapy improves H. Pylori treatment outcomes.
详细描述
Helicobacter pylori (H. Pylori) infection is a wide spread disease and is endemic in many countries including Egypt with a wide range of morbidity; that requires appropriate antimicrobial therapy . However, worldwide the eradication rate following the standard triple therapy is declining and this may necessitates introduction of new antimicrobial agents . On the sight of bearing in vivo and in vitro activity against H. Pylori, the use of different strains of probiotics in treatment of H. Pylori may be thus justifiable, Lactobacillus reuteri (L. reuteri) which through different mechanisms including production of reuterin have anti H.pylori activity have been tried in improving the eradication rates of H.pylori with contradictory results . This study is conducted to test the assumption that addition of L. reuteri to the standard triple therapy in treatment of H. Pylori improves the eradication rates and clinical aspects in H. Pylori infection.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion of patients with these criteria
- •Age: 18-60 years
- •Confirmed H. Pylori infection defined by pathological lesions and either histopathological confirmation of the organism, rapid urease test or H. Pylori antigen in stool
- •Good mentality to understand aim, benefits and steps of the study
- •Assumed availability during the study period
- •Written informed consent
排除标准
- •Exclusion of
- •Patients with chronic diseases e.g. diabetes, renal failure, cirrhosis...etc.
- •Patients with malignancy.
- •Patients with gall bladder disorders.
- •Patients with peptic ulcer.
- •Patients with prior upper GIT surgery.
- •Patients with probiotics therapy in the last one month.
- •Patients with triple therapy, antibiotics, proton pump inhibitors and H2 receptor blockers therapy within one month.
- •Patients with known allergy to the used medications
研究组 & 干预措施
Lactobacillus reuteri group
The active group that will receive the standard triple therapy and Lactobacillus reuteri
干预措施: Lactobacillus reuteri (Dietary Supplement)
Lactobacillus reuteri group
The active group that will receive the standard triple therapy and Lactobacillus reuteri
干预措施: Omeprazole (Drug)
Lactobacillus reuteri group
The active group that will receive the standard triple therapy and Lactobacillus reuteri
干预措施: Amoxicillin (Drug)
Lactobacillus reuteri group
The active group that will receive the standard triple therapy and Lactobacillus reuteri
干预措施: Clarithromycin (Drug)
Control group
The control group that will receive the standard triple therapy and placebo
干预措施: Placebo (Dietary Supplement)
Control group
The control group that will receive the standard triple therapy and placebo
干预措施: Omeprazole (Drug)
Control group
The control group that will receive the standard triple therapy and placebo
干预措施: Amoxicillin (Drug)
Control group
The control group that will receive the standard triple therapy and placebo
干预措施: Clarithromycin (Drug)
结局指标
主要结局
Eradication of H Pylori Infection 4 Weeks After Completion of Therapy
时间窗: 4 weeks therapy
H. pylori eradication is defined in this study as concomitant negativity to all previously positive tests (H. pylori antigen in stool; histopathological confirmation of H. pylori bacilli; and rapid urease test.) 4 weeks after the end of therapy.
次要结局
- The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements.(8 weeks)
- Severe Adverse Effects to the Used Medications and Dietary Supplements.(4 weeks)
研究者
Moahmed Hassan Emara
Lecturer of Tropical Medicine and Hepatogastroenterology
Zagazig University