Inflammatory Bowel Disease (IBD)ELITENCT06502873
Setting up a Cohort of Patients With Inflammatory Bowel Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease
A study testing biological samples collection in people with Inflammatory Bowel Disease (IBD), run by Artialis at 1 site in Belgium.
Trial summary
The objective of this study is to constitute cohorts of IBD versus non-IBD patients to identify (a) new biomarker(s) of intestinal dysbiosis associated with inflammatory bowel disease, and develop a prototype for assaying such marker(s) in blood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (IBD)
- What is being tested?
- biological samples collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Jun 2024to 31 Dec 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General criteria:
- Male or female ≥ 18 years old
- Able to follow the instructions of the study
- Having signed an informed consent
- Specific for Crohn cohort:
- A confirmed diagnosis of IBD
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- Rectal or colonic or ileocolic involvement
- Patients with CD presenting inflammatory flare and disease extent in the colon or ileocolic region with:
- A clinical activity defined by an average of four or more instances of very soft or liquid stools daily or an abdominal pain score of 2 or more OR a CDAI (CD Activity Index) ≥ 220 OR a Harvey-Bradshaw Index > 8 OR a faecal calprotectin ≥ 250 µg/g And
- A endoscopic activity defined by a SES-CD (Simple Endoscopic Score for Crohn Disease) ≥ 6 or a CDEIS (CD Endoscopic Index score) ≥ 7
- Patients with UC presenting inflammatory flare with:
- A clinical activity defined by a modified Mayo score ≥ 3 OR a Simple Clinical Colitis Activity Index ≥5 OR Patient Reported Outcome (PRO2) ≥ 4 with a subscore of rectal bleeding ≥1 OR a faecal calprotectin ≥ 250 µg/g AND An endoscopic activity defined by a Mayo endoscopic sub-score ≥ 2
- Specific for Control cohort:
- Patient with no colonic lesion(s) visible during the endoscopical examination (neither Crohn's nor other colitis nor cancer)
Who cannot join
- General criteria:
- Commercial Pharmaceutical probiotic administration within the previous month
- Treatment with antibiotics (whatever the route of administration) within last 3 months
- Non-remission Cancer or in remission for less than 6 months
- Any contraindication to colonoscopy and/or biopsy, left to PI discretion
- Under guardianship or judiciable protection
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- Pregnant or breastfeeding women
- Currently participating or having participated in the last 3 months to a clinical study with investigational medicine or food supplement
- Specific for Crohn cohort:
- Crohn disease localized only in Ileum
- Inflammatory colon pathology other than Crohn's (infectious, drug-induced,…)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
CHU de Liège
Liège
Claire Mesnil, claire.mesnil@artialis.com
Catherine Van Kemseke, MD
About this study
Official title: Setting up a Cohort of Patients With Inflammatory Bowel Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease in the Context of the Translational Study of Biomarkers of Intestinal Dysbiosis (ELITE Walloon Project)
The objective of this study is to constitute cohorts of IBD versus non-IBD patients to identify (a) new biomarker(s) of intestinal dysbiosis associated with inflammatory bowel disease, and develop a prototype for assaying such marker(s) in blood.
- Conditions
- Inflammatory Bowel Disease (IBD)
- Being tested
- biological samples collection
- Keywords
- cohort, BEV, intestinal dysbiosis
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological samples collectionProcedure or surgery
Collection of biological samples from the same cohorts: faeces, serum, intestinal biopsies
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory bowel disease cohort | Other | 60 patients diagnosed with colonic inflammatory bowel disease Receives: Procedure: biological samples collection |
| Control cohort | Other | 60 control patients without inflammatory bowel diseases Receives: Procedure: biological samples collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients recruited in each cohort
60 patients in IBD cohort and 60 patients in control cohort
Measured: 27 months
number of faeces samples collected in each cohort
60 patients in IBD cohort and 60 patients in control cohort
Measured: 27 months
Number of plasma samples collected in each cohort
60 patients in IBD cohort and 60 patients in control cohort
Measured: 27 months
Number of biopsy samples collected in each cohort
60 patients in IBD cohort and 60 patients in control cohort with 4 colonic biopsies/ patient
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start28 Jun 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, monocentric, study aiming to recruit 2 types of patients (60 inflammatory bowel disease (IBD) suffering patients versus 60 control patients without IBD nor any other known intestinal pathology).
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artialis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Catherine Van Kemseke, MD, Principal investigator, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502873
- Sponsor's protocol ID
- ELITE
- Acronym
- ELITE
- Status last verified
- Jan 2026
- First submitted
- 2 Jul 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Setting up a Cohort of Patients With Inflammatory Bowel Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease in the Context of the Translational Study of Biomarkers of Intestinal Dysbiosis (ELITE Walloon Project)
- ClinicalTrials.gov ID
- NCT06502873
- Acronym / sponsor ID
- ELITE / ELITE
- Conditions
- Inflammatory Bowel Disease (IBD)
- Keywords
- cohort, BEV, intestinal dysbiosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- ArtialisIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Jul 2024 (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.
The objective of this study is to constitute cohorts of IBD versus non-IBD patients to identify (a) new biomarker(s) of intestinal dysbiosis associated with inflammatory bowel disease, and develop a prototype for assaying such marker(s) in blood.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, monocentric, study aiming to recruit 2 types of patients (60 inflammatory bowel disease (IBD) suffering patients versus 60 control patients without IBD nor any other known intestinal pathology).
| Arm | Type | Receives |
|---|---|---|
| Inflammatory bowel disease cohort | Other | Procedure: biological samples collection60 patients diagnosed with colonic inflammatory bowel disease |
| Control cohort | Other | Procedure: biological samples collection60 control patients without inflammatory bowel diseases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female ≥ 18 years old
- Able to follow the instructions of the study
- Having signed an informed consent
- A confirmed diagnosis of IBD
- Rectal or colonic or ileocolic involvement
Key exclusion criteria (11 listed)
- Commercial Pharmaceutical probiotic administration within the previous month
- Treatment with antibiotics (whatever the route of administration) within last 3 months
- Non-remission Cancer or in remission for less than 6 months
- Any contraindication to colonoscopy and/or biopsy, left to PI discretion
- Under guardianship or judiciable protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biological samples collectionCollection of biological samples from the same cohorts: faeces, serum, intestinal biopsies | Procedure or surgery | Control cohort, Inflammatory bowel disease cohort |
Primary outcome
Number of patients recruited in each cohort
Time frame: 27 months
60 patients in IBD cohort and 60 patients in control cohort
number of faeces samples collected in each cohort
Time frame: 27 months
60 patients in IBD cohort and 60 patients in control cohort
Number of plasma samples collected in each cohort
Time frame: 27 months
60 patients in IBD cohort and 60 patients in control cohort
Number of biopsy samples collected in each cohort
Time frame: 27 months
60 patients in IBD cohort and 60 patients in control cohort with 4 colonic biopsies/ patient
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 28 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Catherine Van Kemseke, MD principal investigator
Centre Hospitalier Universitaire de Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biological samples collection in people with Inflammatory Bowel Disease (IBD), run by Artialis at 1 site in Belgium.
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 14 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 28 Jan 2026. 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 Belgium. 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 Bérénice Costes (042670888, berenice.costes@artialis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients recruited in each cohort (time frame: 27 months). The study lists 4 primary outcomes in all. 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 28 Jan 2026.