Effect of Dietary Supplementation With L. Reuteri ProGastria in H. Pylori-infected Adult Subjects Treated Only With Proton Pump Inhibitors
试验速览
- 阶段
- 不适用
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Increase in the number of subjects with treatment success after 28 days of treatment with omeprazole + L. reuteri compared to those given omeprazole + placebo.
研究概览
简要总结
To determine whether simultaneous use of L. reuteri ProGastria and proton pump inhibitors can eradicate H. pylori in humans in the absence of antibiotics.
详细描述
Fifty-six (56) subjects, aged 18-70 years will be recruited from patients with dyspeptic symptoms referred to the clinic for consultation about H. pylori infection and who have not previously been treated for this infection. Patients in whom H. pylori infection is confirmed (by endoscopy with biopsy) and who fulfil the inclusion criteria, will be invited to enter the study. After written consent has been obtained subjects will be randomly allocated to one of two groups, one to receive omeprazole (2x20mg/day) + 1 tablet placebo per day and the other to receive omeprazole (2x20mg/day) + 1 tablet (2x108 CFU L. reuteri) ProGastria per day.
After randomisation on Day 0 of the study, the subjects will also be asked to complete a gastrointestinal symptom rating score (GSRS) to determine baseline symptomology.
Intervention will begin on Day 1 and last for 28 days after which therapy will be stopped. The subjects will be asked to complete the GSRS questionnaire on Day 14 and Day 28. At Day 14, the patients GSRS scores are monitored and the patients interviewed. In those patients where there is a marked deterioration of their condition or symptoms, these will be considered treatment failures and eradication therapy will then be started on Day 15.
The day after therapy is stopped (Day 29), patients symptoms will be assessed. All patients will undergo gastroscopy to determine the presence of H. pylori or not. If H. pylori infection is confirmed (by endoscopy and biopsy staining), these subjects will be given triple therapy to eradicate the infection and followed up on Day 90 of the study.
On Day 29, those patients that no longer complain of symptoms and are shown to be free of H. pylori infection by endoscopy (treatment success group), will continue with no further therapy until Day 90.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18-70 years
- •Infection with H. pylori defined by endoscopic examination with biopsy H. pylori staining
- •Non-ulcer dyspepsia
- •Absence of other pathology as shown by basic clinical laboratory tests (blood and urine) as well as abdominal ultrasound
- •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
结局指标
主要结局
Increase in the number of subjects with treatment success after 28 days of treatment with omeprazole + L. reuteri compared to those given omeprazole + placebo.
时间窗: 28 days
Treatment success is defined as the absence of H. pylori infection as shown by a significant reduction in symptoms on Day 28 and by the absence of H. pylori on gastric biopsy at Day 28.
次要结局
- Fewer patients in the L. reuteri treatment success group with demonstrated presence of H. pylori infection, measured as UBT on Day 90 compared to the placebo treatment success group(3 months)