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

January 7, 2025 updated by: Merel Verweij, Erasmus Medical Center

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3015 GD
        • Erasmus Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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  • Use of antibiotics in the past 8 weeks at the timepoints when blood is withdrawn and feces is collected.
  • Use of probiotics in the past 8 weeks at the timepoints when blood is withdrawn and feces is collected.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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in bloodmicrobiome between recurrence & non recurrence patients.
Time Frame: 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.
From enrollment to the postoperative endoscopy (at 6 months follow-up).

Secondary Outcome Measures

Outcome Measure
Time Frame
o To identify blood biomarkers predicting postoperative recurrence in Crohn's disease.
Time Frame: From enrollment to the postoperative endoscopy (at 6 months follow-up).
From enrollment to the postoperative endoscopy (at 6 months follow-up).
o To identify histological parameters predicting postoperative recurrence in Crohn's disease.
Time Frame: From enrollment to the postoperative endoscopy (at 6 months follow-up).
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.
Time Frame: From enrollment to the postoperative endoscopy (at 6 months follow-up).
From enrollment to the postoperative endoscopy (at 6 months follow-up).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

January 7, 2025

First Submitted That Met QC Criteria

January 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 7, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12313

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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