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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06770140

Acronym

IBDbloom

Enrollment

Registered

2025-01-13

Start date

2025-02-28

Completion date

2027-02-28

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease (CD)

Keywords

Ileocolonic resection, Blood microbiome, Postoperative recurrence

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Yes

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* Use of antibiotics in the past 8 weeks at the timepoints when blood is withdrawn and feces is collected. * Use of probiotics in the past 8 weeks at the timepoints when blood is withdrawn and feces is collected.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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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).

Countries

Netherlands

Contacts

Primary ContactMerel Verweij, MD

m.verweij@erasmusmc.nl+31650033976

Outcome results