Study of Gastroscopy Negative Dyspepsia - Effect of Acid-reducing Treatment and Information on Various Types of Dysmotility.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 35
- 试验地点
- 5
- 主要终点
- Improvement of symptom score
研究概览
简要总结
Study title: Functional dyspepsia -- effect of acid reducing treatment and individualized information.
Summary: 15-20% of all people experience dyspepsia each year. Dyspepsia means pain or discomfort in the upper part of the abdomen. Accompanying symptoms from the esophagus may be present. The most important relevant medical examination is gastroscopy, and if the findings are normal the condition is usually classified as functional dyspepsia.
Several disturbances of function are now known as potential causes of such symptoms, and the optimal choice of treatment may vary.
In the study the investigators plan to examine whether different types of functional disturbances respond differently to medical therapy. In particular, the investigators want to assess whether comprehensive and individualized information will influence the results of therapy. This has not been previously studied systematically.
The investigators also postulate that disturbances of function of the esophagus may cause complaints that should be classified as functional dyspepsia even if the symptoms are atypical. Few studies have been done to evaluate this hypothesis, and there may be potential consequences for choice of appropriate treatment.
In animal models and in humans is recently demonstrated that elevated gastric pH because of anti-ulcer treatment can trigger food allergy. We use a proton pump inhibitor in our study and eventually development of food allergy will influence patient's condition in an observations period. That why we're observing IgE dynamics in our study.
详细描述
Purpose
Functional dyspepsia is a common disorder affecting approximately 25 % of the adult population. Functional dyspepsia is defined from symptoms according to the Rome II criteria. A normal upper endoscopy is also warranted Many of these patients have specific motility disorders. A more accurate diagnosis could mean a more effective treatment.
In this study the patients take several tests in order to make a more specific diagnosis. These include: 24 hour pH-monitoring, oesophagusmanometry, drink test and scintigrafy.
We will study the effect of acid reducing treatment (proton pump inhibitors) on the different dysmotility-types and also the effect of medical information and advise.
We will observe concentrations of total IgE and various specific antibodies against food allergens in serum when taking PPI. Results here can vary dependent on whether the patient has used PPI anytime before or not.
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
- 20 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 - 60 years
- •Rome II criteria fulfilled
- •Helicobacter test negative (urease-test)
- •Informed consent
排除标准
- •Prior gastrointestinal surgery
- •Treatment with proton pump inhibitors / H2 blockers the last 30 days
- •Pregnancy / lactation
- •Current use of NSAIDs
- •Serious psychiatric illness
- •Serious egg allergy
研究组 & 干预措施
Group A
Patients is given thorough information based on the tests taken plus medical treatment.
干预措施: Individualized and comprehensive information (Procedure)
Group A
Patients is given thorough information based on the tests taken plus medical treatment.
干预措施: Lanzo Melt (Drug)
Group B
Patients receive simple written information based on the tests taken plus medical treatment.
干预措施: Lanzo Melt (Drug)
结局指标
主要结局
Improvement of symptom score
时间窗: november 2009-2013
次要结局
未报告次要终点
研究者
Helge Børresen
Dr.
Helse Fonna
