Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome
This study has been completed.
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
First received: April 3, 2008
Last updated: February 17, 2012
Last verified: February 2012
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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
| Enrollment: | 149 |
| Study Start Date: | February 2008 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 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 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
from november 2008: patients aged above 40 with a duration shorter than one year
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: | February 17, 2012 |
| 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 May 21, 2013