Deployment of a biobank for research and identification of biomarkers predicting postoperative Crohn*s disease recurrence: RAP-CD ancillary study

• Conditions: Crohn's disease; inflammatory bowel disease; 10017969

• Registration Number: NL-OMON47935
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 50

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- The percentage of post-operative CD patients, colonized by FimH-expressing<br /><br>bacteria that aggregate with FimH blocker compound (EB8018/TAK018) at month 6<br /><br>and the correlation with endoscopic recurrence, defined as Rutgeerts *i2 and/or<br /><br>intestinal inflammation necessitating start or switch of IBD medication within<br /><br>12 months.<br /><br>- Deployment of a biobank for future research into biomarkers and microbiota<br /><br>predicting postoperative recurrence</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Differences in the level of FimH+ bacteria in stool at baseline<br /><br>(preoperative) versus postsurgery<br /><br>- Differences in adhesion, invasion and total levels of FimH+ bacteria measured<br /><br>in surgically resected tissue and biopsies sampled during colonoscopy.<br /><br>- Correlation between risk factors for postoperative recurrence and level of<br /><br>FimH expressing bacteria<br /><br>- Differences in the stool microbiome profile preoperatively versus<br /><br>postsurgeryand correlation with changes in biomarkers and in clinical and<br /><br>histologic data</p><br>