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

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

ChemIDplus related topics:

Calcium gluconate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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

Biospecimen Description:

Blood and fecal sample

Estimated Enrollment:	350
Study Start Date:	February 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (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 Blodtests: 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 Blodtests: 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:

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

Contacts


Contact: Anne Line OE Engsbro, MD	45-4732-2952	rkalen@ra.dk

Contact: Peter Bytzer, Professor, MD	45-4732-2414	rkpeby@ra.dk

Locations


Denmark
	Medical Departement, Koege Hospital	Recruiting
	Koege, Denmark, 4600
	Principal Investigator: Anne Line OE Engsbro, MD

Sponsors and Collaborators

University Hospital Koge

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

More Information

Responsible Party:	Koege Hospital, Denmark ( Anne Line Oestergaard Engsbro, medical doctor )
Study ID Numbers:	SJ-40
First Received:	April 3, 2008
Last Updated:	April 14, 2008
ClinicalTrials.gov Identifier:	NCT00659763
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

Study placed in the following topic categories:

Digestive System Diseases

Gastrointestinal Diseases

Colonic Diseases

Irritable Bowel Syndrome

Bilirubin

Intestinal Diseases, Parasitic

Intestinal Diseases

Colonic Diseases, Functional

Additional relevant MeSH terms:

Pathologic Processes

Disease

Syndrome

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	University Hospital Koge Statens Serum Institut University of Copenhagen
Information provided by:	University Hospital Koge
ClinicalTrials.gov Identifier:	NCT00659763