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

NCT06770140 | Not Yet Recruiting

• 1 other identifier: 12313
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease (CD)

Keywords

Ileocolonic resection; Blood microbiome; Postoperative recurrence

Outcome Measures

Primary Outcomes (1)

• Differences in bloodmicrobiome between recurrence & non recurrence patients.

  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.

  From enrollment to the postoperative endoscopy (at 6 months follow-up).

Secondary Outcomes (3)

• 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).

Study Arms (3)

Non-recurrence patients

Patients that do not have postoperative recurrence at colonoscopy 6 months after surgery.

Recurrence patients

Patients that do have postoperative recurrence at colonoscopy 6 months after surgery.

Healthy controls

Patients without Inflammatory Bowel Disease

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be identified at the outpatient clinic at the dept. of gastroenterology or department of surgery or at a multidisciplinary meeting.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, feces, biopsies and resection material

Central Study Contacts

Merel Verweij, MD

CONTACT

+31650033976; m.verweij@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 13, 2025

Record last verified: 2024-12

Locations

NL (1)