Clinical trial NCT00659763: Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome
Official title: Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome and the Prevalence of Intestinal Parasites in Patients Suspected of Irritable Bowel Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome
Keywords: IBS
Diagnosis
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Statens Serum Institut
name: University of Copenhagen
First posted: 2008-04-16
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are recruited from primary care.

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.


Eligibility 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

Primary outcomes:
measure: health related quality of life measured by SF-36
timeFrame: baseline and after 1 year
Secondary outcomes:
measure: Symptoms measured by GSRS and GSRS-IBS
timeFrame: baseline, every month for a year and after 1 year
measure: sick days and reduced productivity measured by WPAI:IBS
timeFrame: baseline, every month and after 1 year
measure: differential diagnoses in both arms
timeFrame: 1 year
measure: Health related quality of life measured by IBS-QOL measurement
timeFrame: baseline and after 1 year
measure: The overall satisfaction with the diagnostic strategy
timeFrame: after initial diagnostic work up and after 1 year
measure: 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.
timeFrame: every month and after 1 year
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Medical Departement, Koege Hospital
Study officials:
affiliation: Køge Hospital
name: Anne Line OE Engsbro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Køge Hospital
name: Peter Bytzer, Professor MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.