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Recruiting

NCT Number: NCT06502873

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Liège

Liège, Belgium

Location status: Recruiting

Location contact

Catherine Van Kemseke, MD

PRINCIPAL_INVESTIGATOR

Claire Mesnil

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,…)

Treatment and study plan

Biological samples collection

Procedure

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

Primary outcomes

  1. Number of patients recruited in each cohort

    Time frame: 27 months

    60 patients in IBD cohort and 60 patients in control cohort

  2. number of faeces samples collected in each cohort

    Time frame: 27 months

    60 patients in IBD cohort and 60 patients in control cohort

  3. Number of plasma samples collected in each cohort

    Time frame: 27 months

    60 patients in IBD cohort and 60 patients in control cohort

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Bérénice Costes

CONTACT

[email protected]

042670888

Sponsors and collaborators

Lead sponsor

Artialis

Industry

Registry information

Official study title

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)

Acronym: ELITE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2024
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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