Maastricht IBS Cohort

NCT ID: NCT00775060

Last Updated: 2016-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2024-09-30

Brief Summary

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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

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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

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Irritable Bowel Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* IBS-patients

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ad Masclee, MD, PhD

Role: STUDY_DIRECTOR

Maastricht University Medical Center

Locations

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Maastricht University Medical Center

Maastricht, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Daisy Jonkers, PhD

Role: CONTACT

+31 43 3785021

Facility Contacts

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Daisy Jonkers, PhD

Role: primary

References

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Snijkers 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.

Reference Type DERIVED
PMID: 37791610 (View on PubMed)

Vork 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.

Reference Type DERIVED
PMID: 34458156 (View on PubMed)

Mujagic 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.

Reference Type DERIVED
PMID: 28675524 (View on PubMed)

Other Identifiers

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MEC 08-3-066

Identifier Type: -

Identifier Source: org_study_id

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