The aim of this exploratory study is to isolate and store blood samples, fecal samples, biopsies and fresh frozen resection specimen of CD patients undergoing bowel resection, for the identification of biomarkers predicting postoperative CD…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- The percentage of post-operative CD patients, colonized by FimH-expressing
bacteria that aggregate with FimH blocker compound (EB8018/TAK018) at month 6
and the correlation with endoscopic recurrence, defined as Rutgeerts *i2 and/or
intestinal inflammation necessitating start or switch of IBD medication within
12 months.
- Deployment of a biobank for future research into biomarkers and microbiota
predicting postoperative recurrence
Secondary outcome
- Differences in the level of FimH+ bacteria in stool at baseline
(preoperative) versus postsurgery
- Differences in adhesion, invasion and total levels of FimH+ bacteria measured
in surgically resected tissue and biopsies sampled during colonoscopy.
- Correlation between risk factors for postoperative recurrence and level of
FimH expressing bacteria
- Differences in the stool microbiome profile preoperatively versus
postsurgeryand correlation with changes in biomarkers and in clinical and
histologic data
Background summary
Bowel surgery rates in CD (Crohn*s Disease) patients are high, up to 50% within
10 years after diagnosis. The postoperative disease course is not fully
understood and postoperative recurrence is common, despite different medical
treatment options. More knowledge on the general postoperative disease course
and predictors of postoperative recurrence would be highly valuable, so
patients can be treated accordingly and postoperative recurrence rates may be
lowered in this patient population.
Study objective
The aim of this exploratory study is to isolate and store blood samples, fecal
samples, biopsies and fresh frozen resection specimen of CD patients undergoing
bowel resection, for the identification of biomarkers predicting postoperative
CD recurrence and for future research on postoperative CD disease course
Study design
A multicentre national observational study will be performed
Study burden and risks
There is no additional burden or risk for patients participating in this study.
During the clinically indicated colonoscopies, extra biopsies will be taken.
These biopsies carry a very low risk of complications. Furthermore, during
clinically indicated blood sampling, an additional 30ml of blood will be
obtained for research purposes. We do not anticipate complications from this
procedure.
dr. Molewaterplein 40
Rotterdam 3015 GD
NL
dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Crohn's disease patients of 18 years or older undergoing ileocolonic resection
Exclusion criteria
Patients not meeting the inclusion criteria and patients in whom no signed
informed consent is obtained
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 | NL69975.078.19 |