Irritable Bowel Syndrome
Conditions
Keywords
IBS, Diagnosis
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.
Interventions
OTHERExclusion 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
OTHERClinical diagnosis
Patient fulfill ROME III criteria No Alarm signals Blood tests: FBC, CRP.
Sponsors
Statens Serum Institut
University of Copenhagen
Zealand University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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 from november 2008: patients aged above 40 with a duration shorter than one year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| health related quality of life measured by SF-36 | baseline and after 1 year |
Secondary
| Measure | Time frame |
|---|---|
| sick days and reduced productivity measured by WPAI:IBS | baseline, every month and after 1 year |
| differential diagnoses in both arms | 1 year |
| Symptoms measured by GSRS and GSRS-IBS | baseline, every month for a year and after 1 year |
| The overall satisfaction with the diagnostic strategy | after initial diagnostic work up and after 1 year |
| 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. | every month and after 1 year |
| Health related quality of life measured by IBS-QOL measurement | baseline and after 1 year |
Countries
Denmark
Outcome results
None listed