"Functional Bowel Disorder. Investigation in General Practice"

Irritable Bowel Syndrome Clinical Trial

Official title:

"Functional Bowel Disorder. Investigation in General Practice"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01153295
• Other study ID #: MFF080408-1
• Status: Completed
• Phase: N/A
• First received: June 28, 2010
• Last updated: October 24, 2011
• Start date: December 2008
• Est. completion date: June 2011

Study information

• Verified date: December 2008
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastrointestinal Diseases
• Intestinal Diseases
• Irritable Bowel Syndrome

Intervention

Procedure:
• Clinical diagnosis based on symptom criteria
The diagnosis is based on ROME III criteria, abscence of danger signals and FBC, CRP
• 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

Locations

Country	Name	City	State
Denmark	Research Unit for General Practice, Department of gastroenterology, Odense University hospital	Odense

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern Denmark	Arla Foods, Mejeribrugets Forskningsfond

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health related quality of life		One year	No
Secondary	Findings of organic disease	We will look at the findings of organic disease (for example celiac disease or colorectal cancer) in the two investigation programes.	one year	Yes