Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Assessed decrease H. pylori gastric load by histology after 28 days compared to placebo and assessed by 13C-UBT before and after 28 days use of L. compared to placebo
研究概览
简要总结
Helicobacter pylori colonizes approximately to 50% of the world-wide population.
There is an exigency to find routes alternating to control the infection with an ample perspective but without the complications of induction of resistance to antibiotics. Supplement dietetic with Lactobacillus reuteri (L. reuteri) in humans takes to the colonization of epithelium gastric and this, combined with the observation of which L. reuteri has the capacity to inhibit the growth of H. Pylori and its union to the gastric mucosa, indicates the potential that the native human bacteria control and influence in the colonization in humans.
The acid-lactic bacteria (in particular the lactobacillus) have been studied by their effects in humans infected with H. Pylori with some success to reduce the load of bacteria Studies using supplements with L. reuteri as much in infected symptomatic patients as asymptomatic with H. pylori showed a clear reduction of the load of bacteria after 4 weeks of use and this was concordant with a reduction in the symptoms associated to the infection.
详细描述
The objective of this study is to determine if the dietetic supplementation with a combination of the stock of L. Reuteri (L. reuteri Progastria) is effective to control the load of bacteria and the consequences of the infection in patients infected with H. pylori.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged 18 - 65 years
- •Infection with H. pylori defined as ∆ > 20 ppm in the UBT test
- •Non-ulcer dyspepsia
- •No earlier eradication therapy for H. pylori infection
- •Written informed consent
- •Stated availability throughout the entire study period
- •Mental ability to understand and willingness to fulfil all the details of the protocol
排除标准
- •Duodenal or gastric ulcer
- •MALT lymphoma
- •Penicillin allergy
- •Gastric resection (at any time)
- •First level relatives of gastric cancer patients
- •Absence of GI symptoms
- •Use of NSAIDs, aspirin or other anti-inflammatory drugs within 1 week (for occasional use) or 3 weeks (for chronic use) of inclusion
- •Use of oral antibiotics and/or PPIs and/or H2-antagonists during the 2 weeks prior to ingestion of the study product
- •Pregnancy
- •Participation in other clinical trials
研究组 & 干预措施
placebo
Placebo will be delivered in a chewable tablet form (1.5g per dose)
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Assessed decrease H. pylori gastric load by histology after 28 days compared to placebo and assessed by 13C-UBT before and after 28 days use of L. compared to placebo
时间窗: 28 days
次要结局
- To decrease dyspeptic symptoms before, during and after eradication therapy as assessed by a gastro-intestinal symptom rating scoring within and between L. reuteri and placebo-supplemented subjects(101 days)