NCT01666717

Brief Summary

The purpose of the study is to evaluate fecal metabolites profiles of Inflammatory Bowel Disease(IBD) patients versus healthy controls (HC).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2008

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2012

Completed
Last Updated

August 17, 2012

Status Verified

August 1, 2012

First QC Date

August 14, 2012

Last Update Submit

August 16, 2012

Conditions

Inflammatory Bowel Diseases

Study Arms (2)

Healthy controls (HC)

HC

Inflammatory Bowel Disease (IBD) patients

Crohn's disease (CD), Ulcerative colitis (UC) and pouchitis

Eligibility Criteria

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

Primary care clinic

You may qualify if:

  • Clinical diagnosis of IBD
  • Age \>18 years

You may not qualify if:

  • Use of antibiotics in the preceding month
  • Intake of pre- or probiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KULeuven-UZLeuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (1)

  • De Preter V, Machiels K, Joossens M, Arijs I, Matthys C, Vermeire S, Rutgeerts P, Verbeke K. Faecal metabolite profiling identifies medium-chain fatty acids as discriminating compounds in IBD. Gut. 2015 Mar;64(3):447-58. doi: 10.1136/gutjnl-2013-306423. Epub 2014 May 8.

    PMID: 24811995DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Fecal samples

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor K. Verbeke

Study Record Dates

First Submitted

August 14, 2012

First Posted

August 16, 2012

Study Start

August 1, 2008

Study Completion

May 1, 2012

Last Updated

August 17, 2012

Record last verified: 2012-08

Locations

BE(1)