Role of Lignin in Treatment of Helicobacter Pylori Infection: A Double-blind Placebo-controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Eradication rate
研究概览
简要总结
The goal of this clinical trial is to learn if drug hydrolyzed lignin works to treat H pylori infection in adults. It will also learn about the safety of drug lignin n the sitting of H pylori infection, and if it halts the side effects associated with H pylori triple therapy. The main questions it aims to answer are:
- Does drug hydrolyzed lignin improve the H pylori eradiation rate when it is added to the standard triple therapy used in treatment of H pylori?
- What medical problems do participants experience when taking drug hydrolyzed lignin? Researchers will compare drug hydrolyzed lignin to a placebo (a look-alike substance that contains no drug) to see if drug hydrolyzed lignin works to treat H pylori.
Participants will:
- Take drug hydrolyzed lignin or a placebo every day for 2 weeks beside the standard triple therapy
- Visit the clinic once every 1 week for checkup and questionnaire filling
- Check for H pylori eradication after 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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Adults, older than
- •Gender: all
- •Patient with confirmed diagnosis of H pylori for the first time
- •H pylori treatment naive patients
- •Welling to participate
排除标准
- •Patients with failed H pylori eradication
- •Allergy to the used medications
- •Patients with other structural bowel diseases e.g. celiac disease, ischemic colitis, IBD, chronic diarrhea
- •General debilitating diseases e.g. decompensated cirrhosis, renal failure
研究组 & 干预措施
Group I
This is the study group who will receive the standard triple (proton pump inhibitor, amoxicillin, clarithromycin) therapy plus the hydrolyzed lignin 400 mg
干预措施: Hydrolyzed Lignin (Drug)
Group II
This is the study group who will receive the standard triple therapy (proton pump inhibitor, amoxicillin, clarithromycin) plus the placebo identical in color, shape, and taste with the hydrolyzed lignin
干预措施: Placebo (Other)
结局指标
主要结局
Eradication rate
时间窗: 2 weeks of continuous treatment, followed by 2 weeks of treatment and then testing again for presence\absence of the infection
How much the H pylori eradication rate following the treatment
次要结局
- Safety profile(up to 4 weeks (2 weeks active treatment and 2 weeks after treatment))