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

January 27, 2026 updated by: Artialis

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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,…)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control cohort
60 control patients without inflammatory bowel diseases
Procedure: biological samples collection
Collection of biological samples from the same cohorts: faeces, serum, intestinal biopsies
Other: Inflammatory bowel disease cohort
60 patients diagnosed with colonic inflammatory bowel disease
Procedure: biological samples collection
Collection of biological samples from the same cohorts: faeces, serum, intestinal biopsies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients recruited in each cohort
Time Frame: 27 months
60 patients in IBD cohort and 60 patients in control cohort
27 months
number of faeces samples collected in each cohort
Time Frame: 27 months
60 patients in IBD cohort and 60 patients in control cohort
27 months
Number of plasma samples collected in each cohort
Time Frame: 27 months
60 patients in IBD cohort and 60 patients in control cohort
27 months
Number of biopsy samples collected in each cohort
Time Frame: 27 months
60 patients in IBD cohort and 60 patients in control cohort with 4 colonic biopsies/ patient
27 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Artialis

Investigators

  • Principal Investigator: Catherine Van Kemseke, MD, Centre hospitalier universitaire de Liege

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 2, 2024

First Submitted That Met QC Criteria

July 9, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELITE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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