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

NCT ID: NCT06770140

Last Updated: 2025-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-28

Study Completion Date

2027-02-28

Brief Summary

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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

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Conditions

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Crohn's Disease (CD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-recurrence patients

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

No interventions assigned to this group

Recurrence patients

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

No interventions assigned to this group

Healthy controls

Patients without Inflammatory Bowel Disease

No interventions assigned to this group

Eligibility Criteria

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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* Use of antibiotics in the past 8 weeks at the timepoints when blood is withdrawn and feces is collected.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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Merel Verweij

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Erasmus Medical Center

Rotterdam, South Holland, Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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Merel Verweij, MD

Role: CONTACT

+31650033976

Other Identifiers

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12313

Identifier Type: -

Identifier Source: org_study_id

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