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Completed

NCT Number: NCT00659763

Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Disease Gastrointestinal Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Departement, Koege Hospital

Køge, 4600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Clinical diagnosis

Other

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

Primary outcomes

  1. health related quality of life measured by SF-36

    Time frame: baseline and after 1 year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Collaborators

  • Statens Serum Institut
  • University of Copenhagen

Registry information

Official study title

Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome and the Prevalence of Intestinal Parasites in Patients Suspected of Irritable Bowel Syndrome

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 16, 2008
Registry last updated
Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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