NCT00775060

Brief 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 provide novel therapeutic targets.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2008

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
15 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

April 7, 2016

Status Verified

April 1, 2016

Enrollment Period

15 years

First QC Date

October 16, 2008

Last Update Submit

April 6, 2016

Conditions

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • IBS-patients

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Netherlands

RECRUITING

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Ad Masclee, MD, PhD

    Maastricht University Medical Center

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2008

First Posted

October 17, 2008

Study Start

September 1, 2009

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

April 7, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations