Unraveling the Blood Microbiome in Postoperative Recurrence of Crohn's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Crohn's Disease (CD). Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Differences in bloodmicrobiome between recurrence & non recurrence patients. [Time frame: From enrollment to the postoperative endoscopy (at 6 months follow-up).]
Secondary outcome measures (3)
- 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).]
- 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).]
- 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).]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Erasmus Medical Center — Rotterdam
Identifiers
NCT: NCT06770140 · 12313