Irritable Bowel SyndromeNCT00659763
Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome
An observational study of Irritable Bowel Syndrome, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
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… 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?
- Exclusion diagnosis and Clinical diagnosis
- How many people
- 149 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2008to Nov 2010
- Phase
- Observational
- 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
Study population: Patients are recruited from primary care.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Exclusion diagnosis, Clinical diagnosis
- Keywords
- IBS, Diagnosis
- 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.
Exclusion diagnosisOther
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
Clinical diagnosisOther
Patient fulfill ROME III criteria No Alarm signals Blood tests: FBC, CRP.
| Study group | Role | What they receive |
|---|---|---|
| A | Patients suspected of irritable bowel syndrome referred from GP´s, who fulfill the ROM III criteria for IBS Receives: Other: Exclusion diagnosis | |
| B | Patients suspected of irritable bowel syndrome referred from GP´s, who fulfill he ROME III criteria for IBS Receives: Other: Clinical diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
health related quality of life measured by SF-36
Measured: baseline and after 1 year
Secondary outcomes (6)
Symptoms measured by GSRS and GSRS-IBS
Measured: baseline, every month for a year and after 1 year
sick days and reduced productivity measured by WPAI:IBS
Measured: baseline, every month and after 1 year
differential diagnoses in both arms
Measured: 1 year
Health related quality of life measured by IBS-QOL measurement
Measured: baseline and after 1 year
The overall satisfaction with the diagnostic strategy
Measured: 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.
Measured: every month and after 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startFeb 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Statens Serum Institut, University of Copenhagen
- Responsible party
- Principal investigator, Anne Line Oestergaard Engsbro, Zealand University Hospital
- Investigators
- Anne Line OE Engsbro, MD, Principal investigator, Køge HospitalPeter Bytzer, Professor MD, Study chair, Køge Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659763
- Sponsor's protocol ID
- SJ-40
- Status last verified
- Mar 2019
- First submitted
- 3 Apr 2008
- Last updated
- 28 Mar 2019
- 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 33029843Larsen AR, Engsbro AL, Bytzer P. Screening instruments for anxiety and depression in patients with irritable bowel syndrome are ambiguous. Dan Med J. 2014 Feb;61(2):A4785.
PubMed 24495890Begtrup 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 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome and the Prevalence of Intestinal Parasites in Patients Suspected of Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00659763
- Acronym / sponsor ID
- SJ-40
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS, Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Statens Serum Institut, University of Copenhagen
- Study start
- Feb 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 16 Apr 2008 (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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: Exclusion diagnosisPatients suspected of irritable bowel syndrome referred from GP´s, who fulfill the ROM III criteria for IBS |
| B | – | Other: Clinical diagnosisPatients suspected of irritable bowel syndrome referred from GP´s, who fulfill he ROME III criteria for IBS |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients are recruited from primary care.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- alarm signals
- pregnancy
- comorbid diseases, that interfere with primary endpoint
- medicine and alcohol abuse
- patient do not speak or 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 |
|---|---|---|
| Exclusion diagnosisPatient 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 | Other | A |
| Clinical diagnosisPatient fulfill ROME III criteria No Alarm signals Blood tests: FBC, CRP. | Other | B |
Primary outcome
health related quality of life measured by SF-36
Time frame: baseline and after 1 year
6 secondary outcomes
Symptoms measured by GSRS and GSRS-IBS
Time frame: 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
differential diagnoses in both arms
Time frame: 1 year
Health related quality of life measured by IBS-QOL measurement
Time frame: baseline and after 1 year
The overall satisfaction with the diagnostic strategy
Time frame: 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
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 28 Mar 2019.
- 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 24495890Larsen AR, Engsbro AL, Bytzer P. Screening instruments for anxiety and depression in patients with irritable bowel syndrome are ambiguous. Dan Med J. 2014 Feb;61(2):A4785.
- 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.
Anne Line OE Engsbro, MD principal investigator
Køge Hospital
Peter Bytzer, Professor MD study chair
Køge Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by Zealand University Hospital 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 4 inclusion and 7 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 28 Mar 2019. 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 measured by SF-36 (time frame: baseline and after 1 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 NCT00659763, which also lists 3 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 28 Mar 2019.