"Functional Bowel Disorder. Investigation in General Practice"
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|ClinicalTrials.gov Identifier: NCT01153295|
Recruitment Status : Completed
First Posted : June 30, 2010
Last Update Posted : October 25, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome||Procedure: Clinical diagnosis based on symptom criteria Procedure: Diagnosis of exclusion||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||153 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||"Functional Bowel Disorder. Investigation in General Practice"|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
Experimental: Positive diagnosis
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
The diagnosis is based on ROME III criteria, abscence of danger signals and FBC, CRP
Active Comparator: 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
Procedure: Diagnosis of exclusion
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
- Health related quality of life [ Time Frame: One year ]
- Findings of organic disease [ Time Frame: one year ]We will look at the findings of organic disease (for example celiac disease or colorectal cancer) in the two investigation programes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01153295
|Research Unit for General Practice, Department of gastroenterology, Odense University hospital|
|Odense, Denmark, 5000|
|Principal Investigator:||Ove B. Schaffalitzky de Muckadell, Professor||Odense University Hospital|