Irritable Bowel SyndromeNCT00775060
Maastricht IBS Cohort
An observational study of Irritable Bowel Syndrome, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
To set up a cohort of at least 400 IBS patients in order to identify different patient subgroups according to phenotypical and genotypical patterns and To set up a biobank for future translational studies on the pathophysiology of IBS, in order to identify genetic factors to unravel the pathogenesis of IBS and to… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- How many people
- 600 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2009to Sep 2024
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: At least 400 patients with (suspected) IBS referred to the GI-outpatient clinic of the Maastricht University Medical Center will be asked to participate in the study.
Who may be able to join
- IBS-patients
Who cannot join
- Severe co-morbidity hindering a rectal barostat procedure, according to the gastroenterologist's perception.
- Abdominal surgery, except for uncomplicated appendectomy, laparoscopic cholecystectomy or hysterectomy.
- Inability to stop medication that can influence gastrointestinal motility or perception (like loperamide, butylscopolamine, psylliumsead (metamucil), duspatal, metoclopramide, domperidon, erytromycin and serotonin reuptake inhibitors), for at least 3 days before tests.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht
Daisy Jonkers, PhD, d.jonkers@maastrichtuniversity.nl
Daisy Jonkers, PhD
About this study
Official title: Maastricht IBS Cohort: Phenotypical and Genotypical Characterization of Patients With Irritable Bowel Syndrome.
To set up a cohort of at least 400 IBS patients in order to identify different patient subgroups according to phenotypical and genotypical patterns and
To set up a biobank for future translational studies on the pathophysiology of IBS, in order to identify genetic factors to unravel the pathogenesis of IBS and to provide novel therapeutic targets.
Read the detailed description
Aim of the present study is to set up a large cohort of IBS patients in order to identify different disease characteristics as well as aetiological and pathophysiological factors in (sub)groups of patients with this heterogeneous disorder. Various phenotypical and genotypical markers will be evaluated. For this purpose, blood and faecal samples as well as symptom questionnaires will be collected and visceral perception and intestinal permeability will be measured. In order to increase the sensitivity of the barostat procedure, a pilot study will be performed by measuring patients and healthy controls under meal stimulated and fasting conditions. We aim to set up a biobank for studies on the pathophysiology of IBS, in order to identify genetic factors that may help unravel the pathogenesis of IBS and provide novel therapeutic targets. Consent will be asked to collect data from questionnaires, to store serum samples, DNA, stool and, when endoscopy is performed for clinical reasons, also biopsy specimens.
- Conditions
- Irritable Bowel Syndrome
- Medical subject headings
- Irritable Bowel Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startSep 2009
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ad Masclee, MD, PhD, Study director, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775060
- Sponsor's protocol ID
- MEC 08-3-066
- Status last verified
- Apr 2016
- First submitted
- 16 Oct 2008
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Groen SR, Vork L, Weerts ZZRM, Mujagic Z, Conchillo JM, Masclee AAM, Jonkers DMAE, Keszthelyi D. Phenotyping Increased Urge to Defecate in Irritable Bowel Syndrome: Analysis of Symptom, Sensory, and Psychological Profiles. United European Gastroenterol J. 2026 Sep;14(7):e70287. doi: 10.1002/ueg2.70287.
PubMed 42689492Snijkers JTW, Winkens B, Weerts ZZRM, Vork L, Mujagic Z, Hesselink MAM, Leue C, Kruimel JW, Muris JWM, Jonkers DMAE, Masclee AAM, Keszthelyi D. Satisfaction With Life in IBS Is Associated With Psychological Burden Rather than Gastrointestinal Symptom Severity. Am J Gastroenterol. 2024 Mar 1;119(3):512-520. doi: 10.14309/ajg.0000000000002547. Epub 2023 Oct 4.
PubMed 37791610Vork L, Penders J, Jalanka J, Bojic S, van Kuijk SMJ, Salonen A, de Vos WM, Rajilic-Stojanovic M, Weerts ZZRM, Masclee AAM, Pozuelo M, Manichanh C, Jonkers DMAE. Does Day-to-Day Variability in Stool Consistency Link to the Fecal Microbiota Composition? Front Cell Infect Microbiol. 2021 Jul 20;11:639667. doi: 10.3389/fcimb.2021.639667. eCollection 2021.
PubMed 34458156Mujagic Z, Jonkers DMAE, Ludidi S, Keszthelyi D, Hesselink MA, Weerts ZZRM, Kievit RN, Althof JF, Leue C, Kruimel JW, van Schooten FJ, Masclee AAM. Biomarkers for visceral hypersensitivity in patients with irritable bowel syndrome. Neurogastroenterol Motil. 2017 Dec;29(12). doi: 10.1111/nmo.13137. Epub 2017 Jul 3.
PubMed 28675524
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maastricht IBS Cohort: Phenotypical and Genotypical Characterization of Patients With Irritable Bowel Syndrome.
- ClinicalTrials.gov ID
- NCT00775060
- Acronym / sponsor ID
- MEC 08-3-066
- Conditions
- Irritable Bowel Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 17 Oct 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.
To set up a cohort of at least 400 IBS patients in order to identify different patient subgroups according to phenotypical and genotypical patterns and
To set up a biobank for future translational studies on the pathophysiology of IBS, in order to identify genetic factors to unravel the pathogenesis of IBS and to provide novel therapeutic targets.
Detailed description
Aim of the present study is to set up a large cohort of IBS patients in order to identify different disease characteristics as well as aetiological and pathophysiological factors in (sub)groups of patients with this heterogeneous disorder. Various phenotypical and genotypical markers will be evaluated. For this purpose, blood and faecal samples as well as symptom questionnaires will be collected and visceral perception and intestinal permeability will be measured. In order to increase the sensitivity of the barostat procedure, a pilot study will be performed by measuring patients and healthy controls under meal stimulated and fasting conditions. We aim to set up a biobank for studies on the pathophysiology of IBS, in order to identify genetic factors that may help unravel the pathogenesis of IBS and provide novel therapeutic targets. Consent will be asked to collect data from questionnaires, to store serum samples, DNA, stool and, when endoscopy is performed for clinical reasons, also biopsy specimens.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- At least 400 patients with (suspected) IBS referred to the GI-outpatient clinic of the Maastricht University Medical Center will be asked to participate in the study.
Key inclusion criteria (1 listed)
- IBS-patients
Key exclusion criteria (3 listed)
- Severe co-morbidity hindering a rectal barostat procedure, according to the gastroenterologist's perception.
- Abdominal surgery, except for uncomplicated appendectomy, laparoscopic cholecystectomy or hysterectomy.
- Inability to stop medication that can influence gastrointestinal motility or perception (like loperamide, butylscopolamine, psylliumsead (metamucil), duspatal, metoclopramide, domperidon, erytromycin and serotonin reuptake inhibitors), for at least 3 days before tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
- Derived from this study: PubMed 42689492Groen SR, Vork L, Weerts ZZRM, Mujagic Z, Conchillo JM, Masclee AAM, Jonkers DMAE, Keszthelyi D. Phenotyping Increased Urge to Defecate in Irritable Bowel Syndrome: Analysis of Symptom, Sensory, and Psychological Profiles. United European Gastroenterol J. 2026 Sep;14(7):e70287. doi: 10.1002/ueg2.70287.
- Derived from this study: PubMed 37791610Snijkers JTW, Winkens B, Weerts ZZRM, Vork L, Mujagic Z, Hesselink MAM, Leue C, Kruimel JW, Muris JWM, Jonkers DMAE, Masclee AAM, Keszthelyi D. Satisfaction With Life in IBS Is Associated With Psychological Burden Rather than Gastrointestinal Symptom Severity. Am J Gastroenterol. 2024 Mar 1;119(3):512-520. doi: 10.14309/ajg.0000000000002547. Epub 2023 Oct 4.
- Derived from this study: PubMed 34458156Vork L, Penders J, Jalanka J, Bojic S, van Kuijk SMJ, Salonen A, de Vos WM, Rajilic-Stojanovic M, Weerts ZZRM, Masclee AAM, Pozuelo M, Manichanh C, Jonkers DMAE. Does Day-to-Day Variability in Stool Consistency Link to the Fecal Microbiota Composition? Front Cell Infect Microbiol. 2021 Jul 20;11:639667. doi: 10.3389/fcimb.2021.639667. eCollection 2021.
- Derived from this study: PubMed 28675524Mujagic Z, Jonkers DMAE, Ludidi S, Keszthelyi D, Hesselink MA, Weerts ZZRM, Kievit RN, Althof JF, Leue C, Kruimel JW, van Schooten FJ, Masclee AAM. Biomarkers for visceral hypersensitivity in patients with irritable bowel syndrome. Neurogastroenterol Motil. 2017 Dec;29(12). doi: 10.1111/nmo.13137. Epub 2017 Jul 3.
- Individual participant dataSharing planned: No
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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.
Ad Masclee, MD, PhD study director
Maastricht University Medical Center
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 Maastricht University Medical Center at 1 site in Netherlands.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Apr 2016. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daisy Jonkers, PhD (+31 43 3785021, d.jonkers@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00775060, which also lists 4 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 7 Apr 2016.