Irritable Bowel SyndromeNCT01153295
"Functional Bowel Disorder. Investigation in General Practice"
A study testing Clinical diagnosis based on symptom criteria and Diagnosis of exclusion in people with Irritable Bowel Syndrome, run by University of Southern Denmark at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Clinical diagnosis based on symptom criteria and Diagnosis of exclusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2008to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Fulfill ROME III criteria
- age 18-50 years
- signed informed content
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Research Unit for General Practice, Department of gastroenterology, Odense University hospital
Odense, Odense, 5000
About this study
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.
Read more
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.
Read the 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:
- A positive diagnosis, the diagnosis is based on the ROM III criteria and a few blood tests (FBC, CRP)
- 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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Clinical diagnosis based on symptom criteria, Diagnosis of exclusion
- Keywords
- IBS, Irritable bowel syndrome, diagnosis, safety, Health related quality of life
- Medical subject headings
- Irritable Bowel Syndrome, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical diagnosis based on symptom criteriaProcedure or surgery
The diagnosis is based on ROME III criteria, abscence of danger signals and FBC, CRP
Diagnosis of exclusionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Positive diagnosis | Experimental | The diagnosis of IBS is based on the international ROME III criteria, few blod tests, and abscence of danger signals Receives: Procedure: Clinical diagnosis based on symptom criteria |
| Diagnosis of exclusion | Active comparator | 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 Receives: Procedure: Diagnosis of exclusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life
Measured: One year
Secondary outcomes (1)
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startDec 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Mejeribrugets ForskningsFond, Arla Foods
- Responsible party
- Principal investigator, Luise Molenberg Begtrup, University of Southern Denmark
- Investigators
- Ove B. Schaffalitzky de Muckadell, Professor, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153295
- Sponsor's protocol ID
- MFF080408-1
- Status last verified
- Dec 2008
- First submitted
- 28 Jun 2010
- Last updated
- 25 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Engsbro AL, Begtrup LM, Haastrup P, Storsveen MM, Bytzer P, Kjeldsen J, Schaffalitzky De Muckadell O, Jarbol DE. A positive diagnostic strategy is safe and saves endoscopies in patients with irritable bowel syndrome: A five-year follow-up of a randomized controlled trial. Neurogastroenterol Motil. 2021 Mar;33(3):e14004. doi: 10.1111/nmo.14004. Epub 2020 Oct 7.
PubMed 33029843Begtrup LM, Engsbro AL, Kjeldsen J, Larsen PV, Schaffalitzky de Muckadell O, Bytzer P, Jarbol DE. A positive diagnostic strategy is noninferior to a strategy of exclusion for patients with irritable bowel syndrome. Clin Gastroenterol Hepatol. 2013 Aug;11(8):956-62.e1. doi: 10.1016/j.cgh.2012.12.038. Epub 2013 Jan 26.
PubMed 23357491
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Functional Bowel Disorder. Investigation in General Practice"
- ClinicalTrials.gov ID
- NCT01153295
- Acronym / sponsor ID
- MFF080408-1
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS, Irritable bowel syndrome, diagnosis, safety, Health related quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Mejeribrugets ForskningsFond, Arla Foods
- Study start
- Dec 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 30 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- A positive diagnosis, the diagnosis is based on the ROM III criteria and a few blood tests (FBC, CRP)
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive diagnosis | Experimental | Procedure: Clinical diagnosis based on symptom criteriaThe diagnosis of IBS is based on the international ROME III criteria, few blod tests, and abscence of danger signals |
| Diagnosis of exclusion | Active comparator | Procedure: Diagnosis of exclusionThe 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Fulfill ROME III criteria
- age 18-50 years
- signed informed content
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical diagnosis based on symptom criteriaThe diagnosis is based on ROME III criteria, abscence of danger signals and FBC, CRP | Procedure or surgery | Positive diagnosis |
| Diagnosis of exclusionThe 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 | Procedure or surgery | Diagnosis of exclusion |
Primary outcome
Health related quality of life
Time frame: One year
1 secondary outcome
Findings of organic disease
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2011.
- Derived from this study: PubMed 33029843Engsbro AL, Begtrup LM, Haastrup P, Storsveen MM, Bytzer P, Kjeldsen J, Schaffalitzky De Muckadell O, Jarbol DE. A positive diagnostic strategy is safe and saves endoscopies in patients with irritable bowel syndrome: A five-year follow-up of a randomized controlled trial. Neurogastroenterol Motil. 2021 Mar;33(3):e14004. doi: 10.1111/nmo.14004. Epub 2020 Oct 7.
- Derived from this study: PubMed 23357491Begtrup LM, Engsbro AL, Kjeldsen J, Larsen PV, Schaffalitzky de Muckadell O, Bytzer P, Jarbol DE. A positive diagnostic strategy is noninferior to a strategy of exclusion for patients with irritable bowel syndrome. Clin Gastroenterol Hepatol. 2013 Aug;11(8):956-62.e1. doi: 10.1016/j.cgh.2012.12.038. Epub 2013 Jan 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ove B. Schaffalitzky de Muckadell, Professor principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical diagnosis based on symptom criteria and Diagnosis of exclusion in people with Irritable Bowel Syndrome, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01153295, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2011; AzTrials last refreshed its copy on 29 Oct 2026.