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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47461
Enrollment
266
Registered
2009-10-29
Start date
2010-10-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease inflammatory bowel diseases ulcerative colitis

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)