Unraveling the Blood Microbiome in Postoperative Recurrence of Crohn's Disease
ConditionCrohn's Disease (CD)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorErasmus Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Diagnosis of Crohn's Disease
Adult ≥ 16 years
Undergoing an ileocolonic resection or reresection
Written informed consent
Disqualifiers
Use of antibiotics in the past 8 weeks at the timepoints when blood is withdrawn and feces is collected.
Use of probiotics in the past 8 weeks at the timepoints when blood is withdrawn and feces is collected.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
Trial population
Patients will be identified at the outpatient clinic at the dept. of gastroenterology or department of surgery or at a multidisciplinary meeting.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
70 Participants
are grouped into 3 trial groupsGroup A: Non-recurrence patients
Group B: Recurrence patients
Group C: Healthy controls
Trial outcomes
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.
Time frame
From enrollment to the postoperative endoscopy (at 6 months follow-up).Secondary outcomes
1
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).2
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).3
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: