Anti-bacterial Effects of Ingesting Deep Sea Water in Subjects With H. Pylori Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- to compare the efficacy of DSW and non-DSW drinking water as anti-H. pylori regimen
研究概览
简要总结
Deep sea water (DSW) is characterized by high purity, low temperature, high nutrients and minerals and is obtained from the water flows 200 meters under the surface of the sea. The inhibition of H. pylori growth by DSW has been demonstrated in vitro study. However, up to now, there is few randomized control study to evaluate the anti-bacterial effects of ingesting DSW in patients with H. pylori infection.
The aims of this study are:
- to evaluate the anti-bacterial effects of ingesting DSW in patients with H. pylori infection;
- to evaluate the patient adherence and adverse effects of ingesting DSW.
详细描述
Patients having H. pylori-positive chronic gastritis with/without small erosions or peptic ulcer scars will be recruited. Before treatment, H. pylori infection status will be examined by endoscopy with biopsy or 13C-urea breath test (13C-UBT). All patients will receive 13C-UBT before treatment, at the end of 2 week's treatment and 4 weeks after termination of treatment. A computed generated random numbers sequence will be blocked (2:1; block sizes of six) into two groups, say A and B.
group A - ingesting DSW 200 cc four times a day (one hour before meal and bed time); group B - ingesting non-DSW drinking water 200 cc four times a day (one hour before meal and bed time).
To keep the study in double-blind model, the picture of package for DSW and non-DSW drinking water will be the same.
Prokinetics (metoclopramide 5 mg/tab 1 tid) and antacid (strocain tablet (oxethazaine 5 mg and polymigel 244 mg/tab) 1 tid) will be permitted for relieving the dyspeptic symptoms.
All patients will be asked to complete a questionnaire and to record symptoms and water/drug consumption daily during the treatment period. Post-treatment, the patients will be seen at the Outpatients Clinic to investigate patient adherence and adverse of treatment.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having H. pylori-positive chronic gastritis with/without small erosions or peptic ulcer scars who are aged greater than 20 years and are willing to received anti-H. pylori treatment.
排除标准
- •pregnant or nursing woman
- •serious concomitant illness and malignant tumor of any kind
- •serious bleeding from gastrointestinal tract
- •previous gastric surgery
- •receiving bismuth salts, Proton pump inhibitors, or antibiotics in the previous month.
研究组 & 干预措施
group A: DSW group
ingesting DSW 200 cc four times a day (one hour before meal and bed time);
干预措施: DSW (Drug)
结局指标
主要结局
to compare the efficacy of DSW and non-DSW drinking water as anti-H. pylori regimen
时间窗: 6 months
The eradication rates (efficacy) will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.
次要结局
- to compare the adverse effects and patient adherence of DSW and non-DSW drinking water as anti-H. pylori regimen(6 months)