Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome
NCT ID: NCT00659763
Last Updated: 2019-03-28
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
149 participants
OBSERVATIONAL
2008-02-29
2010-11-30
Brief Summary
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The purpose of the second part of the study is to determine which intestinal parasites the patients have in their bowel and whether these parasites are the cause of the disease.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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A
Patients suspected of irritable bowel syndrome referred from GP´s, who fulfill the ROM III criteria for IBS
Exclusion diagnosis
Patient fulfill ROME III criteria No Alarmsignals Blood tests: FBC,CRP, ALAT, bilirubins, bas.phosphatases, Albumine, TSH, calcium, celiac screening, lactase gene test.
3 consecutive fecal samples for worm, ovaes and parasites Sigmoidoscopy with biopsy
B
Patients suspected of irritable bowel syndrome referred from GP´s, who fulfill he ROME III criteria for IBS
Clinical diagnosis
Patient fulfill ROME III criteria No Alarm signals Blood tests: FBC, CRP.
Interventions
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Exclusion diagnosis
Patient fulfill ROME III criteria No Alarmsignals Blood tests: FBC,CRP, ALAT, bilirubins, bas.phosphatases, Albumine, TSH, calcium, celiac screening, lactase gene test.
3 consecutive fecal samples for worm, ovaes and parasites Sigmoidoscopy with biopsy
Clinical diagnosis
Patient fulfill ROME III criteria No Alarm signals Blood tests: FBC, CRP.
Eligibility Criteria
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Inclusion Criteria
* consultant in general practice for gastrointestinal symptoms, where the GP suspects irritable bowel syndrome
* full fill the ROME III criteria
* signed informed consent
Exclusion Criteria
* pregnancy
* comorbid diseases, that interfere with primary endpoint
* medicine and alcohol abuse
* patient do not speak or understand danish
* investigations for irritable bowel syndrome with in the last 3 years
from november 2008: patients aged above 40 with a duration shorter than one year
18 Years
50 Years
ALL
No
Sponsors
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Statens Serum Institut
OTHER
University of Copenhagen
OTHER
Zealand University Hospital
OTHER
Responsible Party
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Anne Line Oestergaard Engsbro
MD, phD-student
Principal Investigators
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Anne Line OE Engsbro, MD
Role: PRINCIPAL_INVESTIGATOR
Køge Hospital
Peter Bytzer, Professor MD
Role: STUDY_CHAIR
Køge Hospital
Locations
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Medical Departement, Koege Hospital
Køge, , 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.
Larsen AR, Engsbro AL, Bytzer P. Screening instruments for anxiety and depression in patients with irritable bowel syndrome are ambiguous. Dan Med J. 2014 Feb;61(2):A4785.
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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SJ-40
Identifier Type: -
Identifier Source: org_study_id
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