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

Tracking Information

First Received Date ^ICMJE

April 3, 2008

Last Updated Date

November 17, 2009

Start Date ^ICMJE

February 2008

Estimated Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

health related quality of life measured by SF-36 [ Time Frame: baseline and after 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00659763 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

Irritable Bowel Syndrome

Intervention ^ICMJE

Other: Exclusion diagnosis
Other: Clinical diagnosis

Study Arms / Comparison Groups

Patients suspected of irritable bowel syndrome referred from GP´s, who fulfill the ROM III criteria for IBS
Patients suspected of irritable bowel syndrome referred from GP´s, who fulfill he ROME III criteria for IBS

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

350

Estimated Completion Date

November 2011

Estimated Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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:

alarm signals
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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00659763

Responsible Party

Anne Line Oestergaard Engsbro, medical doctor, Koege Hospital, Denmark

Study ID Numbers ^ICMJE

SJ-40

Study Sponsor ^ICMJE

University Hospital Koge

Collaborators ^ICMJE

Statens Serum Institut
University of Copenhagen

Investigators ^ICMJE

Principal Investigator:	Anne Line OE Engsbro, MD	Koege Hospital
Study Chair:	Peter Bytzer, Professor MD	Koege Hospital

Information Provided By

University Hospital Koge

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP