"Functional Bowel Disorder. Investigation in General Practice"

October 24, 2011 updated by: Luise Molenberg Begtrup, University of Southern Denmark

The study aims to investigate how to give the diagnosis of Irritable Bowel Syndrome.

The investigators compare two parallel groups of primary care patients, in the age of 18-50 years with gastrointestinal complaints where the GP suspects IBS. All included patients fulfil international diagnostic criteria (ROME III) and have no danger signals.

Group 1: The diagnosis is based on the diagnostic criteria and few blod tests Group 2: The diagnosis is a diagnosis of exclusion after investigations with extended blod tests, examination for milk- and gluten intolerance, stoll for ova and parasites and scopy of the intestine.

After receiving the diagnosis of Irritable bowel syndrome all patients are informed about the condition.

The investigators follow the patients for 1 year. The investigators hypothesis is that the two investigation programmes (group 1 and 2)are equal with respect to the patients´ quality of life, symptoms and satisfaction and also with respect to finding of organic diseases.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Two opposing approaches can be distinguished in establishing the diagnosis of Irritable Bowel Syndrome (IBS): IBS as a "diagnosis of exclusion" versus IBS as a syndromic condition on its own. In Denmark we have no consensus on how to establish the diagnosis, but must often GPs approach IBS as a diagnosis of exclusion. Guidelines from the United Kingdom and the United States recommend the second approach, where the diagnosis is given as a positive diagnosis based on symptom-based IBS criteria. We lack research on this area carried out under controlled circumstances and in primary care in Denmark.

Aim: To evaluate two investigation programmes for diagnosing IBS in primary care patients in Denmark. We want to compare the two programmes in relation to the effect on the patients´ symptoms, quality of life and satisfaction, and also the cost and safety when using the different programmes. Also we want to see how the GP´s understanding of IBS correlate with the IBS criteria (ROM I, II and III)

Methods: A randomised, non-blinded, controlled intervention study of two parallel groups.

The target group comprises people aged 18-50 years, who consult their GP with gastrointestinal complaints, where the GP suspects IBS and refers the patient to the study.

To be included in the study the patients have to fulfil the ROM III criteria and they may not have any alarm signals. Included patients are randomised to one of two different investigation programmes, where the diagnosis is given as:

  1. A positive diagnosis, the diagnosis is based on the ROM III criteria and a few blood tests (FBC, CRP)
  2. A diagnosis of exclusion, the diagnosis is given after normal investigation (extended blood tests, screening for celiac sprue and lactose intolerance, endoscopy)

The patients are followed by means of monthly letters, with questions about current GI symptoms, sick-leave days, visits at GPs, use of medication etc., and validated questionnaires at baseline, after 4 weeks, 6 months and 12 months.

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Not Applicable

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

  • Denmark
      • Odense, Denmark, 5000
        • Research Unit for General Practice, Department of gastroenterology, Odense University 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

Description

Inclusion Criteria:

  • Fulfill ROME III criteria
  • age 18-50 years
  • signed informed content

Exclusion Criteria:

  • Danger signals (fever, anaemia, weightloss, blod in stools, predisposition for CRC or IBD)
  • abnormal physical examination
  • comorbidity
  • abuse
  • lacking ability to talk and understand danish
  • pregnancy
  • Performed endoscopy within the last 3 years
  • For patients > 40 years. Changed bowel habits, with duration > 3 weeks, but < 1 year
  • Age < 18 years and > 50 years

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Positive diagnosis
The diagnosis of IBS is based on the international ROME III criteria, few blod tests, and abscence of danger signals
Procedure: Clinical diagnosis based on symptom criteria
The diagnosis is based on ROME III criteria, abscence of danger signals and FBC, CRP
ACTIVE_COMPARATOR: Diagnosis of exclusion
The diagnosis of IBS is based on normal extended blood tests, screening for celiac sprue and lactose intolerance, stool for ova and parasites and endoscopy with biopsy
Procedure: Diagnosis of exclusion
The diagnosis is based on normal investigations involving endoscopy with biopsy, stool for ova and parasites, FBC, CRP, TSH, Ca, ALT, alanine aminotransferase; alkaline phosphatase, serum bilirubin, Screening for lactose and celiac sprue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Health related quality of life
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Findings of organic disease
Time Frame: one year
We will look at the findings of organic disease (for example celiac disease or colorectal cancer) in the two investigation programes.
one year

Collaborators and Investigators

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

Sponsor

University of Southern Denmark

Collaborators

Arla Foods
Mejeribrugets ForskningsFond

Investigators

  • Principal Investigator: Ove B. Schaffalitzky de Muckadell, Professor, Odense University 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.

General Publications

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

December 1, 2008

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

June 28, 2010

First Submitted That Met QC Criteria

June 29, 2010

First Posted (ESTIMATE)

June 30, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 25, 2011

Last Update Submitted That Met QC Criteria

October 24, 2011

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MFF080408-1

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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