Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome

NCT ID: NCT00659763

Last Updated: 2019-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

149 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-11-30

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.

Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A

Patients suspected of irritable bowel syndrome referred from GP´s, who fulfill the ROM III criteria for IBS

Exclusion diagnosis

Intervention Type OTHER

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

Clinical diagnosis

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Clinical diagnosis

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Statens Serum Institut

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anne Line Oestergaard Engsbro

MD, phD-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne Line OE Engsbro, MD

Role: PRINCIPAL_INVESTIGATOR

Køge Hospital

Peter Bytzer, Professor MD

Role: STUDY_CHAIR

Køge Hospital

Locations

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Medical Departement, Koege Hospital

Køge, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 33029843 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24495890 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23357491 (View on PubMed)

Other Identifiers

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SJ-40

Identifier Type: -

Identifier Source: org_study_id

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