Crohn's disease inflammatory bowel disease
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Crohn's disease patients of 18 years or older undergoing ileocolonic resection
Exclusion criteria
Exclusion criteria: Patients not meeting the inclusion criteria and patients in whom no signed informed consent is obtained
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - 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
| Measure | Time frame |
|---|---|
| - 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 | — |
Countries
Netherlands
Outcome results
None listed