Clinical trial NCT06502873: Setting up a Cohort of Patients With Crohn's Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease
Official title: Setting up a Cohort of Patients With Crohn's 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn Disease
Lead sponsor: Artialis
Sponsor class: INDUSTRY
First posted: 2024-07-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, monocentric, study aiming to recruit 2 types of patients (60 Crohn's disease (CD) suffering patients versus 60 control patients without IBD nor any other known intestinal pathology).
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to constitute cohorts of Crohn versus non-Crohn patients to identify (a) new biomarker(s) of intestinal dysbiosis associated with Crohn 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 CD
* 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

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,...)

Primary outcomes:
measure: Number of patients recruited in each cohort
timeFrame: 18 months
measure: number of faeces samples collected in each cohort
timeFrame: 18 months
measure: Number of plasma samples collected in each cohort
timeFrame: 18 months
measure: Number of biopsy samples collected in each cohort
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU de Liège
Study officials:
affiliation: Centre Hospitalier Universitaire de Liege
name: Sophie Vieujean, MD
role: PRINCIPAL_INVESTIGATOR
References: