"Functional Bowel Disorder. Investigation in General Practice"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- Health related quality of life
研究概览
简要总结
The study aims to investigate how to give the diagnosis of Irritable Bowel Syndrome.
The investigators compare two parallel groups of primary care patients, in the age of 18-50 years with gastrointestinal complaints where the GP suspects IBS. All included patients fulfil international diagnostic criteria (ROME III) and have no danger signals.
Group 1: The diagnosis is based on the diagnostic criteria and few blod tests Group 2: The diagnosis is a diagnosis of exclusion after investigations with extended blod tests, examination for milk- and gluten intolerance, stoll for ova and parasites and scopy of the intestine.
After receiving the diagnosis of Irritable bowel syndrome all patients are informed about the condition.
The investigators follow the patients for 1 year. The investigators hypothesis is that the two investigation programmes (group 1 and 2)are equal with respect to the patients´ quality of life, symptoms and satisfaction and also with respect to finding of organic diseases.
详细描述
Background: Two opposing approaches can be distinguished in establishing the diagnosis of Irritable Bowel Syndrome (IBS): IBS as a "diagnosis of exclusion" versus IBS as a syndromic condition on its own. In Denmark we have no consensus on how to establish the diagnosis, but must often GPs approach IBS as a diagnosis of exclusion. Guidelines from the United Kingdom and the United States recommend the second approach, where the diagnosis is given as a positive diagnosis based on symptom-based IBS criteria. We lack research on this area carried out under controlled circumstances and in primary care in Denmark.
Aim: To evaluate two investigation programmes for diagnosing IBS in primary care patients in Denmark. We want to compare the two programmes in relation to the effect on the patients´ symptoms, quality of life and satisfaction, and also the cost and safety when using the different programmes. Also we want to see how the GP´s understanding of IBS correlate with the IBS criteria (ROM I, II and III)
Methods: A randomised, non-blinded, controlled intervention study of two parallel groups.
The target group comprises people aged 18-50 years, who consult their GP with gastrointestinal complaints, where the GP suspects IBS and refers the patient to the study.
To be included in the study the patients have to fulfil the ROM III criteria and they may not have any alarm signals. Included patients are randomised to one of two different investigation programmes, where the diagnosis is given as:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfill ROME III criteria
- •age 18-50 years
- •signed informed content
排除标准
- •Danger signals (fever, anaemia, weightloss, blod in stools, predisposition for CRC or IBD)
- •abnormal physical examination
- •comorbidity
- •lacking ability to talk and understand danish
- •pregnancy
- •Performed endoscopy within the last 3 years
- •For patients > 40 years. Changed bowel habits, with duration > 3 weeks, but < 1 year
- •Age < 18 years and > 50 years
研究组 & 干预措施
Positive diagnosis
The diagnosis of IBS is based on the international ROME III criteria, few blod tests, and abscence of danger signals
干预措施: Clinical diagnosis based on symptom criteria (Procedure)
Diagnosis of exclusion
The diagnosis of IBS is based on normal extended blood tests, screening for celiac sprue and lactose intolerance, stool for ova and parasites and endoscopy with biopsy
干预措施: Diagnosis of exclusion (Procedure)
结局指标
主要结局
Health related quality of life
时间窗: One year
次要结局
- Findings of organic disease(one year)
研究者
Luise Molenberg Begtrup
Doctor
University of Southern Denmark