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"Functional Bowel Disorder. Investigation in General Practice"

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ClinicalTrials.gov Identifier: NCT01153295
Recruitment Status : Completed
First Posted : June 30, 2010
Last Update Posted : October 25, 2011
Sponsor:
Collaborators:
Mejeribrugets Forskningsfond
Arla Foods
Information provided by (Responsible Party):
Luise Molenberg Begtrup, University of Southern Denmark

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Procedure: Clinical diagnosis based on symptom criteria Procedure: Diagnosis of exclusion Not Applicable

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  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: "Functional Bowel Disorder. Investigation in General Practice"
Study Start Date : December 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

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




Primary Outcome Measures :
  1. Health related quality of life [ Time Frame: One year ]

Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01153295


Locations
Denmark
Research Unit for General Practice, Department of gastroenterology, Odense University hospital
Odense, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
Mejeribrugets Forskningsfond
Arla Foods
Investigators
Principal Investigator: Ove B. Schaffalitzky de Muckadell, Professor Odense University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luise Molenberg Begtrup, Doctor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01153295     History of Changes
Other Study ID Numbers: MFF080408-1
First Posted: June 30, 2010    Key Record Dates
Last Update Posted: October 25, 2011
Last Verified: December 2008

Keywords provided by Luise Molenberg Begtrup, University of Southern Denmark:
IBS
Irritable bowel syndrome
diagnosis
safety
Health related quality of life

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