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Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome

This study is currently recruiting participants.
Study NCT00659763.   Last updated on April 14, 2008.   Information provided by University Hospital Koge

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Descriptive Information Fields
Brief Title  Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome
Official Title  Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome and the Prevalence of Intestinal Parasites in Patients Suspected of Irritable Bowel Syndrome
Brief Summary

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.

Detailed Description
Study Phase
Study Type  Observational
Study Design  Cohort, Prospective
Primary Outcome Measure  health related quality of life measured by SF-36 [ Time Frame: baseline and after 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Symptoms measured by GSRS and GSRS-IBS [ Time Frame: baseline, every month for a year and after 1 year ] [ Designated as safety issue: No ]
sick days and reduced productivity measured by WPAI:IBS [ Time Frame: baseline, every month and after 1 year ] [ Designated as safety issue: No ]
differential diagnoses in both arms [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Health related quality of life measured by IBS-QOL measurement [ Time Frame: baseline and after 1 year ] [ Designated as safety issue: Yes ]
The overall satisfaction with the diagnostic strategy [ Time Frame: after initial diagnostic work up and after 1 year ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Condition  Irritable Bowel Syndrome
Intervention  Other: Exclusion diagnosis
Other: Clinical diagnosis
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  350
Start Date  February 2008
Completion Date February 2010
Eligibility Criteria 

Inclusion Criteria:

  • age 18-50 years
  • 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
Gender Both
Ages 18 Years to 50 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Anne Line OE Engsbro, MD     45-4732-2952     rkalen@ra.dk    
Contact: Peter Bytzer, Professor, MD     45-4732-2414     rkpeby@ra.dk    
Location Countries  Denmark
Administrative Information Fields
NCT ID  NCT00659763
Organization ID SJ-40
Secondary IDs ††
Study Sponsor  University Hospital Koge
Collaborators †† Statens Serum Institut
University of Copenhagen
Investigators 
Principal Investigator:     Anne Line OE Engsbro, MD     Koege Hospital    
Principal Investigator:     Bo Soendergaard, MD     Koege Hospital    
Study Chair:     Peter Bytzer, Professor MD     Koege Hospital    
Information Provided By University Hospital Koge
Verification Date April 2008
First Received Date  April 3, 2008
Last Updated Date April 14, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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