Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome

NCT00659763 | Completed

• 1 other identifier: SJ-40
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

IBS; Diagnosis

Outcome Measures

Primary Outcomes (1)

• health related quality of life measured by SF-36

  baseline and after 1 year

Secondary Outcomes (6)

• Symptoms measured by GSRS and GSRS-IBS

  baseline, every month for a year and after 1 year

• sick days and reduced productivity measured by WPAI:IBS

  baseline, every month and after 1 year

• differential diagnoses in both arms

  1 year

• Health related quality of life measured by IBS-QOL measurement

  baseline and after 1 year

• The overall satisfaction with the diagnostic strategy

  after initial diagnostic work up and after 1 year

Study Arms (2)

A

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

Other: Exclusion diagnosis

B

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

Other: Clinical diagnosis

Interventions

Exclusion diagnosis 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

A

Clinical diagnosis OTHER

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

B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients are recruited from primary care.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead
• Statens Serum Institut: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Medical Departement, Koege Hospital

Køge, 4600, Denmark

Location

Related Publications (3)

• 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.

  PMID: 33029843 DERIVED

• 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.

  PMID: 24495890 DERIVED

• 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.

  PMID: 23357491 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood and fecal sample

MeSH Terms

Conditions

Irritable Bowel Syndrome; Disease

Interventions

Clinical Laboratory Techniques

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Anne Line OE Engsbro, MD

  Køge Hospital

  PRINCIPAL INVESTIGATOR

• Peter Bytzer, Professor MD

  Køge Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, phD-student

Study Record Dates

• First Submitted: April 3, 2008
• First Posted: April 16, 2008
• Study Start: February 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: March 28, 2019

Record last verified: 2019-03

Locations

DK (1)