Unraveling the Blood Microbiome in Postoperative Recurrence of Crohn's Disease

Not yet recruiting

• Conditions: Crohn's Disease (CD)

• Registration Number: NCT06770140
• Lead Sponsor: Erasmus Medical Center

Brief Summary

Crohn's disease, a chronic inflammation of the gastro-intestinal tract, is a disease with a complex pathogenetic background. Hereditary factors, environmental factors and the gut flora play a varying role in its onset, however, this role remains unclear to date. We hypothesize to detect tiny fragments of microbial DNA from the gut in the bloodstream, due to disruption in the natural defences of the gut lining. If this is true, it may hold the key to understanding why Crohn's disease recurs after surgery.

Our objective in this study is to test retrospectively, if we can detect any difference in microbial DNA from the blood of ileocolonic resection (ICR) patients that do and do not show recurrence at the time of follow-up endoscopy at 6 months.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Study Start: 2025-02
• Primary Completion: 2026-08
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Diagnosis of Crohn's Disease
• Adult ≥ 16 years
• Undergoing an ileocolonic resection or reresection
• Written informed consent

Exclusion Criteria

• Use of antibiotics in the past 8 weeks at the timepoints when blood is withdrawn and feces is collected.
• Use of probiotics in the past 8 weeks at the timepoints when blood is withdrawn and feces is collected.
• Not willing to collect extra biosamples

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in bloodmicrobiome between recurrence & non recurrence patients.	From enrollment to the postoperative endoscopy (at 6 months follow-up).	To test retrospectively, if we can detect any difference in microbial DNA from the blood of ICR patients that do and do not show recurrence, defined as a Rutgeerts score ≥ i2b at the time of follow-up endoscopy at 6 months.

Secondary Outcome Measures

Name	Time	Method
o To identify blood biomarkers predicting postoperative recurrence in Crohn's disease.	From enrollment to the postoperative endoscopy (at 6 months follow-up).
o To identify histological parameters predicting postoperative recurrence in Crohn's disease.	From enrollment to the postoperative endoscopy (at 6 months follow-up).
o To correlate blood biomarkers with fecal biomarkers predicting postoperative recurrence in Crohn's disease.	From enrollment to the postoperative endoscopy (at 6 months follow-up).

Trial Locations

Locations (1)

Erasmus Medical Center; 🇳🇱 Rotterdam, South Holland, Netherlands