NCT06502873 Setting up a Cohort of Patients With Inflammatory Bowel Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease
| NCT ID | NCT06502873 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Artialis |
| Condition | Inflammatory Bowel Disease (IBD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-06-28 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-06-28 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 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 * 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) Exclusion Criteria: 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 * 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,…)
Contact & Investigator
Catherine Van Kemseke, MD
PRINCIPAL INVESTIGATOR
Centre Hospitalier Universitaire de Liege
Frequently Asked Questions
Who can join the NCT06502873 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Inflammatory Bowel Disease (IBD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06502873 currently recruiting?
Yes, NCT06502873 is actively recruiting participants. Contact the research team at berenice.costes@artialis.com for enrollment information.
Where is the NCT06502873 trial being conducted?
This trial is being conducted at Liège, Belgium.
Who is sponsoring the NCT06502873 clinical trial?
NCT06502873 is sponsored by Artialis. The principal investigator is Catherine Van Kemseke, MD at Centre Hospitalier Universitaire de Liege. The trial plans to enroll 120 participants.