Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00659763
• Other study ID #: SJ-40
• Status: Completed
• Start date: February 2008
• Est. completion date: November 2010

Study information

• Verified date: March 2019
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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
• Clinical diagnosis
Patient fulfill ROME III criteria No Alarm signals Blood tests: FBC, CRP.

Locations

Country	Name	City	State
Denmark	Medical Departement, Koege Hospital	Køge

Sponsors (3)

Lead Sponsor	Collaborator
Zealand University Hospital	Statens Serum Institut, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	health related quality of life measured by SF-36		baseline and after 1 year
Secondary	Symptoms measured by GSRS and GSRS-IBS		baseline, every month for a year and after 1 year
Secondary	sick days and reduced productivity measured by WPAI:IBS		baseline, every month and after 1 year
Secondary	differential diagnoses in both arms		1 year
Secondary	Health related quality of life measured by IBS-QOL measurement		baseline and after 1 year
Secondary	The overall satisfaction with the diagnostic strategy		after initial diagnostic work up and after 1 year
Secondary	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