Crohn's Disease (CD)IBDbloomNCT06770140
Unraveling the Blood Microbiome in Postoperative Recurrence of Crohn's Disease
An observational study of Crohn's Disease (CD), run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease (CD)
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2025to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients will be identified at the outpatient clinic at the dept. of gastroenterology or department of surgery or at a multidisciplinary meeting.
Who may be able to join
- Diagnosis of Crohn's Disease
- Adult ≥ 16 years
- Undergoing an ileocolonic resection or reresection
- Written informed consent
Who cannot join
- Use of antibiotics in the past 8 weeks at the timepoints when blood is withdrawn and feces is collected.
- Use of probiotics in the past 8 weeks at the timepoints when blood is withdrawn and feces is collected.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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Erasmus Medical Center
Rotterdam, South Holland, 3015 GD
About this study
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.
- Conditions
- Crohn's Disease (CD)
- Keywords
- Ileocolonic resection, Blood microbiome, Postoperative recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the postoperative endoscopy (at 6 months follow-up).
Secondary outcomes (3)
o To identify blood biomarkers predicting postoperative recurrence in Crohn's disease.
Measured: From enrollment to the postoperative endoscopy (at 6 months follow-up).
o To identify histological parameters predicting postoperative recurrence in Crohn's disease.
Measured: 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.
Measured: From enrollment to the postoperative endoscopy (at 6 months follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's Disease (CD)Studies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merel Verweij, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770140
- Sponsor's protocol ID
- 12313
- Acronym
- IBDbloom
- Status last verified
- Dec 2024
- First submitted
- 7 Jan 2025
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unraveling the Blood Microbiome in Postoperative Recurrence of Crohn's Disease
- ClinicalTrials.gov ID
- NCT06770140
- Acronym / sponsor ID
- IBDbloom / 12313
- Conditions
- Crohn's Disease (CD)
- Keywords
- Ileocolonic resection, Blood microbiome, Postoperative recurrence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be identified at the outpatient clinic at the dept. of gastroenterology or department of surgery or at a multidisciplinary meeting.
Key inclusion criteria (4 listed)
- Diagnosis of Crohn's Disease
- Adult ≥ 16 years
- Undergoing an ileocolonic resection or reresection
- Written informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease (CD), run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merel Verweij, MD (+31650033976, m.verweij@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in bloodmicrobiome between recurrence & non recurrence patients. (time frame: From enrollment to the postoperative endoscopy (at 6 months follow-up).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.