Evaluation of a Health Food Supplement Containing Anti-Helicobacter Pylori Urease IgY Antibody on Patients With Chronic Gastritis in Hanoi, Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- UBT Values at Baseline and 8 Weeks
研究概览
简要总结
H. pylori positive patient volunteers that passed the selection criteria are recruited and divided into a test and a control group. Both groups are treated with a current treatment regime (EAC: Esomeprazole 40 mg/day; Clarithromycin 1000 mg/day; Amoxicillin 2000 mg/day) but only the test group received IgY-containing food supplement as an adjunctive measure for 15 days. The subjects are examined before and 4 weeks after the treatment initiation by Urea Breath Test (UBT) and gastro-endoscopy.
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
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with gastritis or gastric ulcer who are positive to H. pylori
排除标准
- •People allergic to egg proteins
研究组 & 干预措施
Food supplement GastimunHP
The subjects take food supplement containing specific IgY (GastimunHP) during treatment with routine medical regime
干预措施: GastimunHP (Dietary Supplement)
Control
The subjects undergo the routine treatment regime without taking food supplement
结局指标
主要结局
UBT Values at Baseline and 8 Weeks
时间窗: 8 weeks
Urea Breath test (UBT) value was examined at baseline (0 week) and 8 weeks later. A commercial kit was used following the instructions from the manufacturer. A cut off value of 50 is considered to be positive. Higher UBT values indicate worse outcome.
次要结局
- Number of Participants With a Reduction in Gastrointestinal Symptom Rating Scale (GSRS) Scores at 1 and 4 Weeks(4 weeks)
- Number of Participants With a Reduction in Severity of Abdominal Pain at 1 and 4 Weeks(4 weeks)