Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome - Full Text View

Sponsor:	University Hospital Koge
Collaborators:	Statens Serum Institut University of Copenhagen
Information provided by (Responsible Party):	Anne Line Oestergaard Engsbro, University Hospital Koge
ClinicalTrials.gov Identifier:	NCT00659763

Purpose

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	Intervention
Irritable Bowel Syndrome	Other: Exclusion diagnosis Other: Clinical diagnosis

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome and the Prevalence of Intestinal Parasites in Patients Suspected of Irritable Bowel Syndrome

Further study details as provided by University Hospital Koge:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Biospecimen Retention: Samples With DNA

Blood and fecal sample

Estimated Enrollment:	350
Study Start Date:	February 2008
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A 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
B 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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients are recruited from primary care.

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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659763

Locations

Denmark
Medical Departement, Koege Hospital
Koege, Denmark, 4600

Sponsors and Collaborators

University Hospital Koge

Statens Serum Institut

University of Copenhagen

Investigators

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

More Information

No publications provided

Responsible Party:	Anne Line Oestergaard Engsbro, MD, phD-student, University Hospital Koge
ClinicalTrials.gov Identifier:	NCT00659763 History of Changes
Other Study ID Numbers:	SJ-40
Study First Received:	April 3, 2008
Last Updated:	October 13, 2011
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics; Denmark: Danish Dataprotection Agency; Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University Hospital Koge:

IBS
Diagnosis

Additional relevant MeSH terms:

Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases

Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on February 12, 2012