Functional Bowel Disorder. Investigation in General Practice

Study Overview
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Brief Summary
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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.

Detailed Description
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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: A positive diagnosis, the diagnosis is based on the ROM III criteria and a few blood tests (FBC, CRP) A diagnosis of exclusion, the diagnosis is given after normal investigation (extended blood tests, screening for celiac sprue and lactose intolerance, endoscopy) The patients are followed by means of monthly letters, with questions about current GI symptoms, sick-leave days, visits at GPs, use of medication etc., and validated questionnaires at baseline, after 4 weeks, 6 months and 12 months.

Official Title
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Functional Bowel Disorder. Investigation in General Practice

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Procedure: Clinical diagnosis based on symptom criteria
* Procedure: Diagnosis of exclusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fulfill ROME III criteria age 18-50 years signed informed content Exclusion Criteria: Danger signals (fever, anaemia, weightloss, blod in stools, predisposition for CRC or IBD) abnormal physical examination comorbidity abuse 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive diagnosis<br>The diagnosis of IBS is based on the international ROME III criteria, few blod tests, and abscence of danger signals | Procedure: Clinical diagnosis based on symptom criteria<br>* The diagnosis is based on ROME III criteria, abscence of danger signals and FBC, CRP<br>|
| Active Comparator: Diagnosis of exclusion<br>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 | Procedure: Diagnosis of exclusion<br>* The diagnosis is based on normal investigations involving endoscopy with biopsy, stool for ova and parasites, FBC, CRP, TSH, Ca, ALT, alanine aminotransferase; alkaline phosphatase, serum bilirubin, Screening for lactose and celiac sprue<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Findings of organic disease | We will look at the findings of organic disease (for example celiac disease or colorectal cancer) in the two investigation programes. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBS, Irritable bowel syndrome, diagnosis, safety, Health related quality of life