Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome

This study has been completed.
Sponsor:
Collaborators:
Statens Serum Institut
University of Copenhagen
Information provided by (Responsible Party):
Anne Line Oestergaard Engsbro, University Hospital Koge
ClinicalTrials.gov Identifier:
NCT00659763
First received: April 3, 2008
Last updated: February 17, 2012
Last verified: February 2012
  Purpose

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 Intervention
Irritable Bowel Syndrome
Other: Exclusion diagnosis
Other: Clinical diagnosis

Study Type: Observational
Study Design: 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

Further study details as provided by University Hospital Koge:

Primary Outcome Measures:
  • health related quality of life measured by SF-36 [ Time Frame: baseline and after 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptoms measured by GSRS and GSRS-IBS [ Time Frame: baseline, every month for a year and after 1 year ] [ Designated as safety issue: No ]
  • sick days and reduced productivity measured by WPAI:IBS [ Time Frame: baseline, every month and after 1 year ] [ Designated as safety issue: No ]
  • differential diagnoses in both arms [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Health related quality of life measured by IBS-QOL measurement [ Time Frame: baseline and after 1 year ] [ Designated as safety issue: Yes ]
  • The overall satisfaction with the diagnostic strategy [ Time Frame: after initial diagnostic work up and after 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood and fecal sample


Enrollment: 149
Study Start Date: February 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659763

Locations
Denmark
Medical Departement, Koege Hospital
Koege, Denmark, 4600
Sponsors and Collaborators
University Hospital Koge
Statens Serum Institut
University of Copenhagen
Investigators
Principal Investigator: Anne Line OE Engsbro, MD Koege Sygehus
Study Chair: Peter Bytzer, Professor MD Koege Sygehus
  More Information

No publications provided by University Hospital Koge

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne Line Oestergaard Engsbro, MD, phD-student, University Hospital Koge
ClinicalTrials.gov Identifier: NCT00659763     History of Changes
Other Study ID Numbers: SJ-40
Study First Received: April 3, 2008
Last Updated: February 17, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University Hospital Koge:
IBS
Diagnosis

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 20, 2014