Efficacy of Helicobacter Pylori Eradication on Symptoms of Functional Dyspepsia - A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Treatment Success
研究概览
简要总结
This study is designed to study benefit of eradicating Helicobacter Pylori in patients with functional dyspepsia as compared to symptomatic treatment only. Helicobacter pylori positive patients with Functional Dyspepsia will be divided into two study groups, one will receive Helicobacter pylori eradication therapy and other will receive symptomatic treatment. Symptom relief based on Likert scale will be compared in both groups.
详细描述
Functional dyspepsia (FD), is a common problem with many associations. About 50% of the patients with FD have coexistent Helicobacter pylori (HP) associated gastritis.
Many investigators have tried to treat FD by means of eradication of HP infection. Different studies have reported various estimates of association between HP eradication and improvement of dyspeptic symptoms, and whether eradication of HP infection improves dyspeptic symptoms in patients with FD remains controversial because of scarcity of large randomised controlled studies, and great heterogeneity in study designs. Also, antibiotic use or misuse is widely prevalent; the resultant high frequency of antibiotic resistance implies that treatment regimens for HP eradication may not be effective. On this background, the investigators propose to conduct a large tertiary centre based study to find the effect of eradicating HP on the symptoms of FD. Secondarily, the investigators also propose to look for prevalence of HP in FD and recurrence rate of HP infection at 6 month follow up after the eradication therapy.
The investigators hypothesise that HP eradication is superior to Standard of care symptomatic management in treating symptoms of FD.
Primary Objectives:
• To study the effect of HP eradication on symptom profile of Functional 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
- None
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
- •Patients fulfilling the ROME-IV criteria of Functional Dyspepsia
- •Signed informed consent.
排除标准
- •Pregnant and lactating females
- •Patients with predominant symptoms of heartburn or irritable bowel syndrome; alarm symptoms; history of peptic ulcer, upper gastrointestinal tract surgery, or biliary colic
- •Previous treatment for eradication of H pylori.
- •Known allergies to study medication or alcohol or drug abuse.
- •Use of antibiotics or bismuth during the 4 weeks before enrolment, proton pump inhibitors during the 2 weeks before enrolment, or treatment with histamine-2 receptor blockers in the week before enrolment will not be permitted.
- •Patients unable to answer the study questionnaires.
- •Patients unwilling or unable to provide consent.
- •Patient on HIV/AIDS medications, blood thinners, clopidogrel, cyclosporine, digoxin, iron supplements, fluconazole or ketoconazole, probenecid, rifabutin, sildenafil, tacrolimus, theophylline, sulfa drugs, cholesterol-lowering medicines, heart rhythm medications, sedatives, seizure medications, or tetracycline antibiotics.
研究组 & 干预措施
Helicobacter pylori eradication therapy Group
Patients with Functional Dyspepsia receiving two week course of triple drug regimen for H pylori eradication followed by six weeks of proton pump inhibitors
干预措施: Clarithromycin 500mg (Drug)
Helicobacter pylori eradication therapy Group
Patients with Functional Dyspepsia receiving two week course of triple drug regimen for H pylori eradication followed by six weeks of proton pump inhibitors
干预措施: Amoxicillin 1000 MG (Drug)
Helicobacter pylori eradication therapy Group
Patients with Functional Dyspepsia receiving two week course of triple drug regimen for H pylori eradication followed by six weeks of proton pump inhibitors
干预措施: Pantoprazole 40mg (Drug)
Symptomatic treatment group
Patients with Functional Dyspepsia receiving symptomatic therapy with proton pump inhibitors or gastric prokinetics
干预措施: Pantoprazole 40mg (Drug)
Symptomatic treatment group
Patients with Functional Dyspepsia receiving symptomatic therapy with proton pump inhibitors or gastric prokinetics
干预措施: Levosulpiride (Drug)
Symptomatic treatment group
Patients with Functional Dyspepsia receiving symptomatic therapy with proton pump inhibitors or gastric prokinetics
干预措施: Acotiamide (Drug)
Symptomatic treatment group
Patients with Functional Dyspepsia receiving symptomatic therapy with proton pump inhibitors or gastric prokinetics
干预措施: Itopride (Drug)
结局指标
主要结局
Treatment Success
时间窗: Six months after the completion of intervention
Treatment success defined as absence of symptoms or minimal symptoms (GOS score \<3) with GOS reduction by at least 2, 6 months after treatment.
次要结局
- Prevalence of Helicobacter pylori infection in Functional Dyspepsia(At enrolment)
- Efficacy of Helicobacter pylori eradication therapy(Four weeks after the completion of intervention)
- Rate of Helicobacter pylori reinfection(Six months after the completion of intervention)
研究者
Piyush Ranjan
Professor
Sir Ganga Ram Hospital