Aim of this study is to analyse the microbiota, and its variation throughout time in patients with IBD with molecular microbial profiling techniques.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
The intestinal microbiota is implicated as an essential factor in the
pathogenesis of IBD, although the exact role remains elusive. Consistent
findings from the literature showed that the intestinal microbiota of patients
with inflammatory bowel diseases (IBD) is different from that in healthy
individuals and unstable over time. However, only very few patients are studied
in-depth yet. In addition, results from the few studies currently available are
difficult to compare due to differences in methodology e.g. different study
populations or techniques used.
Since most intestinal bacteria are uncultivable, rapid, highly reproducible
methods for high throughput bacterial profiling have been developed and
optimised at our institute.
Study objective
Aim of this study is to analyse the microbiota, and its variation throughout
time in patients with IBD with molecular microbial profiling techniques.
Study design
A prospective longitudinal observational study is conducted. Faecal samples and
rectal swabs are collected at each visit to the outpatient clinic. A short
questionnaire is conducted. Disease activity is determined according to
standardized indices. Regular inflammation parameters are determined in blood
samples and faecal samples. If patient is scheduled for regular colonoscopy
during remission mucosal biopsy specimens are harvested. All samples are
analysed with IS-pro and a subset of samples with 454 pyrosequencing and qPCR
in order to obtain bacterial profiles. Stratification based on patient
subgroups will be applied.
Study burden and risks
Participating patients are asked to collect a faecal sample and rectal swab
each subsequent visit, with a maximum of six times. In case a regular
diagnostic colonoscopy is performed mucosal biopsy specimens are harvested,
besides the usual biopsy specimens for regular histologic examination.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL29131.029.09 |