"Functional Bowel Disorder. Investigation in General Practice"
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Intestinal Diseases
Study type: Interventional

Summary: 
      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: 
      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:

        1. A positive diagnosis, the diagnosis is based on the ROM III criteria and a few blood
           tests (FBC, CRP)

        2. 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.
    

Intervention name(s): Clinical diagnosis based on symptom criteria; Diagnosis of exclusion
Intervention type(s): Procedure; Procedure
Intervention description(s): The diagnosis is based on ROME III criteria, abscence of danger signals and FBC, CRP; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: IBS; Irritable bowel syndrome; diagnosis; safety; Health related quality of life