"Functional Bowel Disorder. Investigation in General Practice"
NCT ID: NCT01153295
Last Updated: 2011-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
153 participants
INTERVENTIONAL
2008-12-31
2011-06-30
Brief Summary
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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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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Positive diagnosis
The diagnosis of IBS is based on the international ROME III criteria, few blod tests, and abscence of danger signals
Clinical diagnosis based on symptom criteria
The diagnosis is based on ROME III criteria, abscence of danger signals and FBC, CRP
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
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
Interventions
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Clinical diagnosis based on symptom criteria
The diagnosis is based on ROME III criteria, abscence of danger signals and FBC, CRP
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
Eligibility Criteria
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Inclusion Criteria
* age 18-50 years
* signed informed content
Exclusion Criteria
* 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
18 Years
50 Years
ALL
No
Sponsors
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Mejeribrugets ForskningsFond
OTHER
Arla Foods
INDUSTRY
University of Southern Denmark
OTHER
Responsible Party
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Luise Molenberg Begtrup
Doctor
Principal Investigators
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Ove B. Schaffalitzky de Muckadell, Professor
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Locations
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Research Unit for General Practice, Department of gastroenterology, Odense University hospital
Odense, Odense, Denmark
Countries
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References
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Engsbro AL, Begtrup LM, Haastrup P, Storsveen MM, Bytzer P, Kjeldsen J, Schaffalitzky De Muckadell O, Jarbol DE. A positive diagnostic strategy is safe and saves endoscopies in patients with irritable bowel syndrome: A five-year follow-up of a randomized controlled trial. Neurogastroenterol Motil. 2021 Mar;33(3):e14004. doi: 10.1111/nmo.14004. Epub 2020 Oct 7.
Begtrup LM, Engsbro AL, Kjeldsen J, Larsen PV, Schaffalitzky de Muckadell O, Bytzer P, Jarbol DE. A positive diagnostic strategy is noninferior to a strategy of exclusion for patients with irritable bowel syndrome. Clin Gastroenterol Hepatol. 2013 Aug;11(8):956-62.e1. doi: 10.1016/j.cgh.2012.12.038. Epub 2013 Jan 26.
Other Identifiers
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MFF080408-1
Identifier Type: -
Identifier Source: org_study_id