Setting up a Cohort of Patients With Inflammatory Bowel Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease (ELITE)

Artialis

Status: Enrolling

Conditions: Inflammatory Bowel Disease (IBD)

Treatments: Procedure: biological samples collection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06502873

ELITE

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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,…)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Inflammatory bowel disease cohort

Other group

Description:

60 patients diagnosed with colonic inflammatory bowel disease

Treatment:

Procedure: biological samples collection

Control cohort

Other group

Description:

60 control patients without inflammatory bowel diseases

Treatment:

Procedure: biological samples collection