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

NCT06502873 | Recruiting

• 1 other identifier: ELITE
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease (IBD)

Keywords

cohort; BEV; intestinal dysbiosis

Outcome Measures

Primary Outcomes (4)

• Number of patients recruited in each cohort

  60 patients in IBD cohort and 60 patients in control cohort

  27 months

• number of faeces samples collected in each cohort

  60 patients in IBD cohort and 60 patients in control cohort

  27 months

• Number of plasma samples collected in each cohort

  60 patients in IBD cohort and 60 patients in control cohort

  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

  27 months

Study Arms (2)

Inflammatory bowel disease cohort

OTHER

60 patients diagnosed with colonic inflammatory bowel disease

Procedure: biological samples collection

Control cohort

OTHER

60 control patients without inflammatory bowel diseases

Procedure: biological samples collection

Interventions

biological samples collection PROCEDURE

Collection of biological samples from the same cohorts: faeces, serum, intestinal biopsies

Control cohort; Inflammatory bowel disease cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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,…)

Sponsors & Collaborators

• Artialis: lead

Study Sites (1)

CHU de Liège

Liège, Belgium

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Catherine Van Kemseke, MD

  Centre Hospitalier Universitaire de Liege

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bérénice Costes

CONTACT

042670888; berenice.costes@artialis.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 16, 2024
• Study Start: June 28, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)