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
- to decrease H. pylori gastric load
研究概览
简要总结
Helicobacter pylori colonises an estimated 50% of the world´s population (Taylor & Blaser, 1991; Go, 2002). Despite clear clinical guidelines on the treatment of this infection (Malfertheiner et al. 2007) there is a drive to find alternative ways to control this infection in a wider perspective without the complications of induction of antibiotic resistance in the pathogen.
L. reuteri has been widely studied in clinical trials and has been shown to have probiotic, health-promoting effects in both adults and children (Connolly 2004; Casas & Dobrogosz, 2000). L. reuteri has been shown in numerous studies to be safe for human consumption and it has been shown to colonise the human gastrointestinal tract (Wolf et al., 1995, Valeur et al., 2004).
Studies using supplementation with L. reuteri in both symptomatic and non-symptomatic H. pylori-infected subjects show a clear reduction of infection load after 4 weeks of use and this was concomitant with a reduction in symptoms associated with the infection (Imase et al. 2007; Francavilla et al. 2007, unpublished data). Further, dietary supplementation with L. reuteri during and after the period of H. pylori eradication therapy has also been shown to reduce the side effects of this therapy without affecting the degree of eradication (Lionetti et al., 2007). It is also feasible, through the inhibitory action of L. reuteri on H. pylori, that pre-exposure to L. reuteri may weaken H. pylori and make it more susceptible to antibiotic attack during eradication.
However, an earlier pilot study was not been able to demonstrate a reduction in gastric inflammation caused by H. pylori. This pilot study was performed with L. reuteri ATCC 55730 that has since been found to lack anti-inflammatory activity in in vitro screens. Recent selection of natural, human L. reuteri strains has identified a specific strain with strong anti-inflammatory properties in vitro (Lin et al, 2007 and submitted 2007). A combination of this strain, together with the earlier proven L. reuteri strain, is expected to lead to both a reduction of H. pylori load as well as a reduction in the gastric inflammation related to the pathogen.
详细描述
INVESTIGATIONAL PLAN AND PROCEDURES Randomised, double-blind, placebo-controlled clinical trial. One hundred (100) subjects, aged 18-65 years recruited from patients with symptoms referred for consultation about H. pylori infection naive to treatment. HP infected patients will then be randomly allocated to two groups, one to receive L. reuteri and the other to receive an identical placebo preparation.
Baseline tests:
- 13C-UBT
- Gastrointestinal symptom rating score (GSRS)
- Serological assessment of H. pylori
- Measurement of marker serum peptides related to gastric inflammation.
The subjects will be asked to take the study product each day for 28 days. On Day 29, the subjects will return to the clinic for repeated analysis of:
- 13C-UBT
- Gastrointestinal symptom rating score (GSRS)
- Measurement of marker serum peptides related to gastric inflammation.
- Endoscopy with the collection of 5 gastric biopsy samples (4 from the antrum and 1 from the corpus).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •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
- •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
'L. reuteri DSM 17938 and ATCC PTA 6475
L. reuteri will be delivered at a dose of 1x108 CFU of each strain of L. reuteri giving a final dose of L. reuteri of 2x108 CFU. One dose is to be taken once per day giving a dose of L. reuteri of 2x108 CFU/day.
干预措施: L. reuteri DSM 17938 and ATCC PTA 6475 (Dietary Supplement)
Placebo
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
to decrease H. pylori gastric load
时间窗: 28 days
Primary Outcome Measures: Decrease H. pylori gastric load by histology after 28 days compared to placebo and by 13C-UBT compared to placebo.
次要结局
- To decrease dyspeptic symptoms(28 days)
研究者
Ruggiero Francavilla
MD, PhD
University of Bari