Evaluation of IgY Antibodies Effectiveness in Egg Yolk Against Helicobacter Pylori in Removing Bacteria and Improving Clinical Symptoms in the Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Respiratory urea level (UBT) higher than cut off 50
研究概览
简要总结
- Investigating its effectiveness in removing bacteria in invivo conditions
- Investigating the effectiveness in improving the clinical symptoms of patients
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with gastritis or stomach ulcers whose Helicobacter infection has been confirmed by a doctor and age group 18 to 78 years, all genders, if accepted
排除标准
- •Acute perforation of esophagus, stomach and duodenum Hyperlipidemic people Those who are allergic to egg proteins Patients with stomach cancer
研究组 & 干预措施
Intervention
12 grams of egg yolk powder containing about 2 grams of antibody twice a day for 2 weeks along with usual antibiotic treatment including OAC or omeprazole (40 mg/day), clarithromycin (1000 mg/day) and amoxicillin (2000 mg/day).
干预措施: Helicobacter pylori eradication therapy (Biological)
结局指标
主要结局
Respiratory urea level (UBT) higher than cut off 50
时间窗: Determination of respiratory urea (UBT) at the beginning of the study and 8 weeks after the start of the intervention
This test is performed with the help of a diagnostic kit. After oral ingestion of a capsule containing labeled carbon and the patient's exhalation into the kit, the amount of urea breathed in is determined by the device. A UBT value greater than 50 means Helicobacter pylori infection.
次要结局
- Examining the patient's clinical symptoms including: abdominal pain, nausea, vomiting and bloating.(During the treatment period for 4 weeks from the beginning of the intervention.)
研究者
zahra esmaeili
Student
Mashhad University of Medical Sciences