Effect of Eradication of Helicobacter Pylori on the Dyspeptic Symptoms.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 370
- 试验地点
- 1
- 主要终点
- Improvement in Dyspeptic Symptoms after eradication of Helicobacter Pylori in Patients with Functional Dyspepsia
研究概览
简要总结
Helicobacter pylori eradication and its impact on symptoms in patients with non-ulcer dyspepsia remain controversial . Many studies have examined the effect of H. pylori eradication on dyspeptic symptoms, but the results have been conflicting and inconclusive, with as many studies yielding positive as negative results. Some studies have shown a significant (although weak) symptomatic improvement after H. pylori eradication, and while other yielding negative results. A recent Cochrane review has comprehensively demonstrated that H.pylori eradication therapy has a small but statistically significant effect in H.pylori positive non-ulcer dyspepsia. An economic model suggests this modest benefit may still be cost effective . However it is difficult to reconcile these results in areas with very high prevalence of H. pylori infection such as Pakistan since no such studies have been conducted in developing countries.
The investigators hypothesize that eradication of Helicobacter pylori (H. pylori) leads to a sustained improvement in symptoms of patients diagnosed with H. pylori associated functional (non-ulcer) dyspepsia.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory adult males and non-pregnant females.
- •Dyspeptic symptoms for at least 3 months.
- •Normal endoscopic findings.
- •H. Pylori positive on testing.
排除标准
- •Patients with erosive and non erosive esophagitis.
- •Barrette's esophagus.
- •Duodenal Ulcer, Gastric Ulcer or gastric erosions.
- •Patients with known sensitivity to antibiotics.
- •Patients with severe concomitant systemic disease.
- •Patients with upper GI surgery except cholecystectomy.
- •Females with pregnancy or breast-feeding.
- •Malignancy
- •Alarm symptoms such as bleeding per rectum, hematemesis, and severe weight loss.
研究组 & 干预措施
1.H.Pylori Eradication Group
The eradication group will receive triple therapy (omeprazole 20mg BID for 1 week along with Clarithromycin 500mg BID and Amoxycillin 1g BID) for 1 week for the eradication of H. pylori
干预措施: Omeprazole + Clarithromycin + Amoxycillin (Drug)
2.Control Placebo Group
The control group will receive omeprazole 20 mg BID for 1 week along with placebo antibiotics for 1 week
干预措施: Omeprazole + placebo antibiotics (Drug)
结局指标
主要结局
Improvement in Dyspeptic Symptoms after eradication of Helicobacter Pylori in Patients with Functional Dyspepsia
时间窗: 1 year
次要结局
- To determine whether eradication of Helicobacter Pylori improves the quality of life in patients with Functional Dyspepsia i.Quality of life (QoL) assessment on the basis of SF-36.(1 year)