Intestinal Microbial profiling by means of IS-pro: towards a novel biomarker for inflammatory bowel disease

Recruiting

Conditions: 10017969
Crohn's disease
inflammatory bowel diseases
ulcerative colitis

Registration Number: NL-OMON47461

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 266

Inclusion Criteria

* Age 18 years to 70 years
* Informed Consent (IC)
* Established diagnosis of CD or UC for more than six months, based on
clinical, endoscopic, radiologic and histologic characteristics

Exclusion Criteria

* Use of antibiotics 1 month prior to the trial
* Extensive surgery for Crohn*s disease or ulcerative
colitis*
* Recent myocardial infarction or unstable angina pectoris
* Suspected acute peritonitis or perforation
* Pregnancy
* Contraindications for harvesting biopsy specimens

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>We expect to obtain proof of principle showing how the microbial composition of<br /><br>the intestine might be a biomarker for:<br /><br>- subtypes of inflammatory bowel disease<br /><br>- localization of inflammatory bowel disesase (as described in the Montreal<br /><br>classification)<br /><br>- activity of inflammatory bowel disease, and a potential early indicator of<br /><br>exacerbation</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>IS-pro, a novel powerful molecular bacterial profiling method will be validated<br /><br>to be introduced as a new high-throughput approach to characterize the<br /><br>intestinal microbiota in a routine laboratory setting. This technique will be<br /><br>compared to novel molecular profiling techniques, such as 454 pyrosequencing or<br /><br>qPCR as gold standard of characterization of complex microbial communities.<br /><br>For diagnostic application, profiles derived from standardized mucosal biopsy<br /><br>specimens will be compared to those derived from faecal samples and rectal<br /><br>swabs. With the comparison of these samples, we intend to verify the validity<br /><br>of faecal profiles as a proxy for mucosal profiles, thus providing a<br /><br>non-invasive diagnostic tool.</p><br>