---
title: Setting up a Cohort of Patients With Inflammatory Bowel Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease
nct_id: NCT06502873
overall_status: RECRUITING
phase: NA
sponsor: Artialis
study_type: INTERVENTIONAL
primary_condition: Inflammatory Bowel Disease (IBD)
countries: Belgium
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06502873.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06502873"
ct_last_update_post_date: 2026-01-28
last_seen_at: "2026-05-12T06:19:24.314Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Setting up a Cohort of Patients With Inflammatory Bowel Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease

**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)

**NCT ID:** [NCT06502873](https://clinicaltrials.gov/study/NCT06502873)

## Key Facts

- **Status:** RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 120
- **Lead Sponsor:** Artialis
- **Conditions:** Inflammatory Bowel Disease (IBD)
- **Start Date:** 2024-06-28
- **Completion Date:** 2026-12-31
- **CT.gov Last Update:** 2026-01-28

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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,…)
```

## Arms

- **Inflammatory bowel disease cohort** (OTHER) — 60 patients diagnosed with colonic inflammatory bowel disease
- **Control cohort** (OTHER) — 60 control patients without inflammatory bowel diseases

## Interventions

- **biological samples collection** (PROCEDURE) — Collection of biological samples from the same cohorts: faeces, serum, intestinal biopsies

## Primary Outcomes

- **Number of patients recruited in each cohort** _(time frame: 27 months)_ — 60 patients in IBD cohort and 60 patients in control cohort
- **number of faeces samples collected in each cohort** _(time frame: 27 months)_ — 60 patients in IBD cohort and 60 patients in control cohort
- **Number of plasma samples collected in each cohort** _(time frame: 27 months)_ — 60 patients in IBD cohort and 60 patients in control cohort
- **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

## Locations (1)

- CHU de Liège, Liège, Belgium — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.chu de liège|liège||belgium` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06502873.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06502873*  
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