Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome
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|ClinicalTrials.gov Identifier: NCT00659763|
Recruitment Status : Completed
First Posted : April 16, 2008
Last Update Posted : March 28, 2019
The purpose of this study is to determine whether a clinical diagnosis of irritable bowel syndrome based on patient reported symptoms and a few blood tests is safe, and to determine whether a clinical diagnosis is as good for the patient and as economical for the society as a diagnosis based on exclusion of a number of organic diseases by performing a number of blood tests, fecal analyzes and a scopic examination of bowel.
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.
|Condition or disease||Intervention/treatment|
|Irritable Bowel Syndrome||Other: Exclusion diagnosis Other: Clinical diagnosis|
|Study Type :||Observational|
|Actual Enrollment :||149 participants|
|Official Title:||Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome and the Prevalence of Intestinal Parasites in Patients Suspected of Irritable Bowel Syndrome|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
Patients suspected of irritable bowel syndrome referred from GP´s, who fulfill the ROM III criteria for IBS
Other: 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
Patients suspected of irritable bowel syndrome referred from GP´s, who fulfill he ROME III criteria for IBS
Other: Clinical diagnosis
Patient fulfill ROME III criteria No Alarm signals Blood tests: FBC, CRP.
- health related quality of life measured by SF-36 [ Time Frame: baseline and after 1 year ]
- Symptoms measured by GSRS and GSRS-IBS [ Time Frame: baseline, every month for a year and after 1 year ]
- sick days and reduced productivity measured by WPAI:IBS [ Time Frame: baseline, every month and after 1 year ]
- differential diagnoses in both arms [ Time Frame: 1 year ]
- Health related quality of life measured by IBS-QOL measurement [ Time Frame: baseline and after 1 year ]
- The overall satisfaction with the diagnostic strategy [ Time Frame: after initial diagnostic work up and after 1 year ]
- The use of resources in the health care system measured by the number of doctor visits, ambulatory visits, emergency room visits, hospitalizations and diagnostic tests over 1 year follow up. [ Time Frame: every month and after 1 year ]
Biospecimen Retention: Samples With DNA
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): NCT00659763
|Medical Departement, Koege Hospital|
|Køge, Denmark, 4600|
|Principal Investigator:||Anne Line OE Engsbro, MD||Køge Hospital|
|Study Chair:||Peter Bytzer, Professor MD||Køge Hospital|