ONE WEEK VS. TWO WEEKS VONOPRAZAN CONTAINING TRIPLE REGIMEN FOR ERADICATION OF HELICOBACTER PYLORI:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- Efficacy of triple therapy in eradication of H.pylori (based on duration)
研究概览
简要总结
- To assess the efficacy of the duration of Vonoprazan based triple regimen (one versus two weeks), in the eradication of H-pylori among patients attending gastroenterology clinics of Karachi, Pakistan.
- To assess the improvement in the quality of life of patients receiving Vonoprazan as part of the triple regimen.
详细描述
Introduction
The overall aim of the study is to assess the efficacy of one week of Vonoprazan compared to two weeks of Vonoprazan in eradicating H-Pylori in patients with dyspeptic symptoms.
H. pylori is a pathogenic Gram-negative spiral bacillus that survives in the acid environment of the stomach. It is a leading cause of chronic gastritis, peptic ulcers, non-ulcer dyspepsia, gastric adenocarcinoma and mucosa-associated lymphoid tissue (MALT) lymphoma. It is estimated that up to 50% of the total world population are infected with H. pylori. The prevalence of H. Pylori infection is currently rising in the developing world. Modified one-week triple therapy (two antibiotics for a week and a potassium-competitive acid blocker for 4-8 weeks) represents the most advanced prescribed regimen for H. pylori infection. With current and widely used therapeutic regimens, (such as two antibiotics and a proton pump inhibitor) there is a significant failure rate for the eradication of microorganism. Therefore, interventions that can improve H-pylori eradication along with improving patient's quality of life are highly important.
Vonoprazan is a potassium-competitive acid blocker, which inhibits the H+/K+ pump in the stomach. Unlike proton pump inhibitors, Vonoprazan inhibits the pump in a competitive and reversible manner. Hence, it is expected to be at least as effective as PPIs in the elimination of Helicobacter Pylori. Assessing the duration of Vonoprazan based triple therapy is of great concern.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 ≥ 18 years
- •H pylori infection confirmed by any of the 3 tests C-urea breath test (UBT), , rapid urease test, and stool H pylori antigen.
排除标准
- •acute gastrointestinal disease (e.g., acute diarrhea)
- •chronic gastrointestinal disease (e.g., inflammatory bowel disease, celiac disease)
- •known renal and/or liver failure
- •no known malignancy
- •varices bleeding
研究组 & 干预措施
2 weeks vonoprazan containing triple regimen
For two weeks:
Vonaprazan: 20 mg twice daily Amoxicillin: 1gm twice daily Levofloxacin: 500 mg once daily
干预措施: Vonoprazan, Amoxicillin, Levofloxacin (Drug)
1 week vonoprazan containing triple regimen
For One week:
Vonaprazan: 20 mg twice daily Amoxicillin: 1gm twice daily Levofloxacin: 500 mg once daily
For the second week:
Placebo
干预措施: Vonoprazan, Amoxicillin, Levofloxacin (Drug)
结局指标
主要结局
Efficacy of triple therapy in eradication of H.pylori (based on duration)
时间窗: 6 months
a) To assess the efficacy of the duration of Vonoprazan based triple regimen (one versus two weeks), in the eradication of H-pylori among patients attending gastroenterology clinics of Karachi, Pakistan. The eradication of H.pylori will be tested using the Urea breath test 6 weeks post treatment.
次要结局
- Quality of life assessment using QoLRAD (quality of life in reflux and dyspepsia)(6 months)
研究者
SHAHAB ABID
Professor Of Medicine
Aga Khan University