Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome

March 27, 2019 updated by: Anne Line Oestergaard Engsbro, Zealand University Hospital

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

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

149

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Køge, Denmark, 4600
        • Medical Departement, Koege Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients are recruited from primary care.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Patients suspected of irritable bowel syndrome referred from GP´s, who fulfill the ROM III criteria for IBS

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
health related quality of life measured by SF-36
Time Frame: baseline and after 1 year
baseline and after 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

April 3, 2008

First Submitted That Met QC Criteria

April 14, 2008

First Posted (Estimate)

April 16, 2008

Study Record Updates

Last Update Posted (Actual)

March 28, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

March 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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