Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome and the Prevalence of Intestinal Parasites in Patients Suspected of Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Other: Exclusion diagnosis
* Other: Clinical diagnosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Patients suspected of irritable bowel syndrome referred from GP´s, who fulfill the ROM III criteria for IBS | Other: Exclusion diagnosis<br>* 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<br>|
| B<br>Patients suspected of irritable bowel syndrome referred from GP´s, who fulfill he ROME III criteria for IBS | Other: Clinical diagnosis<br>* Patient fulfill ROME III criteria No Alarm signals Blood tests: FBC, CRP.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health related quality of life measured by SF-36 |  | baseline and after 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms measured by GSRS and GSRS-IBS |  | baseline, every month for a year and after 1 year | 
| sick days and reduced productivity measured by WPAI:IBS |  | baseline, every month and after 1 year | 
| differential diagnoses in both arms |  | 1 year | 
| Health related quality of life measured by IBS-QOL measurement |  | baseline 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBS, Diagnosis