Effectiveness of GastimunHp Plus in Supporting the Treatment of Peptic Ulcer Disease With Helicobacter Pylori Infection
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Proportion of patients with negative urea breath test after 6-8 weeks
研究概览
简要总结
Challenges in the treatment of Helicobacter pylori (H. pylori) include increasing antimicrobial resistance and patient's low tolerance to some regimens. Lactobacillus johnsonii (L. johnsonii) and Immunoglobulin Y (IgY) have been shown to decrease the amount and activity of H. pylori in human stomach and can increase patient's tolerance. We conduct a single-center double-masked randomized controlled trial to evaluate the effectiveness of GastimunHp Plus (a product combining L. johnsonii and IgY) in improving the clearance of H. pylori after six to eight weeks of treatment and side effects of H. pylori treatment. H. pylori is tested by C13- or C14-urea breath test.
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)
盲法说明
The investigational product (IP) is compared with a placebo. The IP and placebo are manufactured by the sponsor and then sent to the trial pharmacist. They are only different in a number in the package label, and only the sponsor knows which number is the IP and will call them "product I" and "product II". This labelling is not revealed to the study team, the trial pharmacist, and the biostatistician.
In the random number sequences generated by the biostatistician, the study numbers will be allocated to either "product I" or "product II". The trial pharmacist is responsible for making product bags using study numbers and allocation given by the biostatistician. The product bags are transferred to the study team. In this way, the study team and patients are completely masked to the allocation.
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with gastritis, duodenitis, or peptic ulcer.
- •Tested positive with Helicobacter pylori using C13- or C14-urea breath test or urease test.
- •Indicated for Helicobacter pylori eradication.
排除标准
- •Suspected malignant lesions.
- •Children under 10 years of age; pregnant or lactating women.
- •Allergic to chicken egg.
结局指标
主要结局
Proportion of patients with negative urea breath test after 6-8 weeks
时间窗: Six to eight weeks after recruitment
Patients tested negative with Helicobacter pylori using C13- or C14-urea breath test.
次要结局
- Proportion of patients with adverse effects(Six to eight weeks after recruitment)
- Proportion of patients with improvement of lesions on endoscopy(Six to eight weeks after recruitment)
- Proportion of patients with clinical improvement after 6-8 weeks(Six to eight weeks after recruitment)