Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome

• ClinicalTrials.gov Identifier: NCT00659763
• Recruitment Status: Completed
• First Posted: April 16, 2008
• Last Update Posted: March 28, 2019
• Sponsor: Zealand University Hospital
• Collaborators: Statens Serum Institut; University of Copenhagen
• Information provided by (Responsible Party): Anne Line Oestergaard Engsbro, Zealand University Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Irritable Bowel Syndrome	Other: Exclusion diagnosis; Other: Clinical diagnosis

Study Design

• Study Type: Observational
• Actual Enrollment: 149 participants
• 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
• Study Start Date: February 2008
• Actual Primary Completion Date: November 2010
• Actual Study Completion Date: November 2010

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. health related quality of life measured by SF-36 [ Time Frame: baseline and after 1 year ]

Secondary Outcome Measures :

1. Symptoms measured by GSRS and GSRS-IBS [ Time Frame: baseline, every month for a year and after 1 year ]
2. sick days and reduced productivity measured by WPAI:IBS [ Time Frame: baseline, every month and after 1 year ]
3. differential diagnoses in both arms [ Time Frame: 1 year ]
4. Health related quality of life measured by IBS-QOL measurement [ Time Frame: baseline and after 1 year ]
5. The overall satisfaction with the diagnostic strategy [ Time Frame: after initial diagnostic work up and after 1 year ]
6. 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 ]

Biospecimen Retention:   Samples With DNA

Blood and fecal sample

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• 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

Locations

Denmark

Medical Departement, Koege Hospital

Køge, Denmark, 4600

Sponsors and Collaborators

Zealand University Hospital

Statens Serum Institut

University of Copenhagen

Investigators

• Principal Investigator: Anne Line OE Engsbro, MD; Køge Hospital
• Study Chair: Peter Bytzer, Professor MD; Køge Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Engsbro AL, Begtrup LM, Haastrup P, Storsveen MM, Bytzer P, Kjeldsen J, Schaffalitzky De Muckadell O, Jarbøl 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, Jarbøl 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.

• Responsible Party: Anne Line Oestergaard Engsbro, MD, phD-student, Zealand University Hospital
• ClinicalTrials.gov Identifier: NCT00659763
• Other Study ID Numbers: SJ-40
• First Posted: April 16, 2008
• Last Update Posted: March 28, 2019
• Last Verified: March 2019

Keywords provided by Anne Line Oestergaard Engsbro, Zealand University Hospital:

IBS; Diagnosis

Additional relevant MeSH terms:

Irritable Bowel Syndrome; Syndrome; Disease; Pathologic Processes; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases