NCT03150394Unknown4 期
A Randomized, Double-blind, Placebo-controlled Study of the Usefulness of the Probiotic 'Lactobacillus Reuteri' in the Therapy of Quadruple Eradication of Helicobacter Pylori Infection in Usual Clinical Practice
Dr. Luis Fernandez2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年4月4日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Global score of gastrointestinal symptoms assessed according the GSRS scale
研究概览
简要总结
Helicobacter pylori is a Gram-negative bacterium with a helical bacillus shape that it's able to penetrate and colonize the stomach mucosal lining by infecting it.
The eradication treatment of H. pylori is supported by numerous consensus groups worldwide and it is generally safe and well tolerated. Standard treatment is based on multiple drug regimens. However, its effectiveness has been increasingly compromised due to the emergence of resistant strains, as well as poor adherence to treatment. Therefore, it's proposed a randomized, double-blind, placebo-controlled study whose aims are:
- Determine whether the combination of two probiotic strains of L reuteri (Gastrus) will improve gastrointestinal symptoms when associated with four-way therapy (of any type).
- Prove whether supplementation with Gastrus (food supplement) versus Placebo is able to reduce the gastrointestinal adverse effects of quadruple eradication therapy.
They will be determined by the GSRS gastrointestinal symptom scale in routine 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
- 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
- 否
入选标准
- •Patients attended at the clinic visit who present a positive diagnosis of H pylori infection using different diagnostic techniques (C13 breath test, histology, urease and / or H pylori antigen in stools).
- •Age between 18 and 65 years
排除标准
- •Patients taking other probiotics 4 weeks prior to study start.
- •Patients who have previously received eradicating therapy.
- •Patients who are treated with NSAIDs, aspirin or other anti-inflammatory drugs either on an occasional basis (one week prior to the study) or on a chronic basis (3 weeks prior to inclusion).
- •Patients who have used oral antibiotics two weeks prior to inclusion.
- •Pregnancy
研究组 & 干预措施
Treatment of quadruple eradication therapy with GASTRUS
Experimental
干预措施: GASTRUS (Dietary Supplement)
Treatment of quadruple eradication therapy with PLACEBO
Placebo Comparator
干预措施: PLACEBO (Other)
结局指标
主要结局
Global score of gastrointestinal symptoms assessed according the GSRS scale
时间窗: 30 days
次要结局
- Score obtained from each individual gastrointestinal symptom evaluated according the GSRS scale. Percentage of patients completing treatment(60 days)
研究者
Dr. Luis Fernandez
PhD
Hospital Clínico Universitario de Valladolid
研究点 (2)
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