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Recruiting NCT06502873

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

No phase Interventional Inflammatory Bowel Disease (IBD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: biological samples collection.
Who it may be relevant to
Registry conditions: Inflammatory Bowel Disease (IBD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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)

Overview

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.

Interventions

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

Primary outcome measures

  • Number of patients recruited in each cohort [Time frame: 27 months]
  • number of faeces samples collected in each cohort [Time frame: 27 months]
  • Number of plasma samples collected in each cohort [Time frame: 27 months]
  • Number of biopsy samples collected in each cohort [Time frame: 27 months]

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 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,…)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

Belgium · 1 center
  • CHU de Liège — Liège

Identifiers

NCT: NCT06502873 · ELITE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗