Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome - Tabular View

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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

This Tabular View shows the required WHO registration data elements as marked by ^†

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

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.