Cohort study of patients with and without Crohn's disease
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)
This study is trying to find new markers in the blood that can help us understand Crohn's disease better by comparing patients with Crohn's to those without any bowel issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Artialis Industry-sponsored |
| Locations | 1 site (Liège) |
| Trial ID | NCT06502873 on ClinicalTrials.gov |
What this trial studies
This study aims to establish cohorts of patients with Crohn's disease and those without chronic inflammatory bowel disease to identify new biomarkers associated with Crohn's disease. The approach involves collecting biological samples from participants to analyze intestinal dysbiosis. By comparing the two groups, researchers hope to develop a prototype for assaying these biomarkers in blood, which could lead to improved diagnostics and understanding of the disease.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of Crohn's disease experiencing an inflammatory flare.
Not a fit: Patients without any colonic lesions or those who do not meet the specific criteria for Crohn's disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the identification of new biomarkers that improve the diagnosis and management of Crohn's disease.
How similar studies have performed: While similar studies have explored biomarkers in Crohn's disease, this specific approach of comparing cohorts with and without the disease to identify dysbiosis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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,…)
Where this trial is running
Liège
- CHU de Liège — Liège, Belgium (Recruiting)
Study contacts
- Principal investigator: Catherine Van Kemseke, MD — Centre Hospitalier Universitaire de Liege
- Study coordinator: Bérénice Costes
- Email: berenice.costes@artialis.com
- Phone: 042670888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.