- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00659763
Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome
Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome and the Prevalence of Intestinal Parasites in Patients Suspected of Irritable Bowel Syndrome
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Køge, Denmark, 4600
- Medical Departement, Koege Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
A
Patients suspected of irritable bowel syndrome referred from GP´s, who fulfill the ROM III criteria for IBS
|
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
|
Patient fulfill ROME III criteria No Alarm signals Blood tests: FBC, CRP.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
health related quality of life measured by SF-36
Time Frame: baseline and after 1 year
|
baseline and after 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Symptoms measured by GSRS and GSRS-IBS
Time Frame: baseline, every month for a year and after 1 year
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baseline, every month for a year and after 1 year
|
sick days and reduced productivity measured by WPAI:IBS
Time Frame: baseline, every month and after 1 year
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baseline, every month and after 1 year
|
differential diagnoses in both arms
Time Frame: 1 year
|
1 year
|
Health related quality of life measured by IBS-QOL measurement
Time Frame: baseline and after 1 year
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baseline and after 1 year
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The overall satisfaction with the diagnostic strategy
Time Frame: after initial diagnostic work up and after 1 year
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after initial diagnostic work up and after 1 year
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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
|
every month and after 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne Line OE Engsbro, MD, Køge Hospital
- Study Chair: Peter Bytzer, Professor MD, Køge Hospital
Publications and helpful links
General Publications
- Engsbro AL, Begtrup LM, Haastrup P, Storsveen MM, Bytzer P, Kjeldsen J, Schaffalitzky De Muckadell O, Jarbol DE. A positive diagnostic strategy is safe and saves endoscopies in patients with irritable bowel syndrome: A five-year follow-up of a randomized controlled trial. Neurogastroenterol Motil. 2021 Mar;33(3):e14004. doi: 10.1111/nmo.14004. Epub 2020 Oct 7.
- Larsen AR, Engsbro AL, Bytzer P. Screening instruments for anxiety and depression in patients with irritable bowel syndrome are ambiguous. Dan Med J. 2014 Feb;61(2):A4785.
- Begtrup LM, Engsbro AL, Kjeldsen J, Larsen PV, Schaffalitzky de Muckadell O, Bytzer P, Jarbol DE. A positive diagnostic strategy is noninferior to a strategy of exclusion for patients with irritable bowel syndrome. Clin Gastroenterol Hepatol. 2013 Aug;11(8):956-62.e1. doi: 10.1016/j.cgh.2012.12.038. Epub 2013 Jan 26.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SJ-40
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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