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Clinical Trials in France / NCT06690632
Recruiting Not applicable

WAter Preparation in Crohn's Disease's Imagery

NCT06690632 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Toulouse
Phase
Not applicable
Started
2025-01-29
Last updated
2026-05-08

Condition(s) studied

Crohn Disease (CD)

Investigational drug(s) / intervention(s)

water preparationpolyethylene glycol preparation

water preparation: ingestion of 1.5L of water 30min prior MRE acquisition

polyethylene glycol preparation: ingestion of 1.5L of water diluted PEG 45 min prior MRE acquisition (standard protocol)

Study summary

The goal of this clinical trial is to compare distension quality and patient experience of water and polyethylene glycol preparation as oral contrast media in Magnetic Resonance Enterography (MRE) in patients with Crohn's disease.

Thus, the main question it aims to answer is:

Is water sufficient to interpret MRE from patients with Crohn's disease?

Researchers will compare the standard protocol (polyethylene glycol) with water as bowel distension agent to see if it is possible to obtain a satisfying global distension of small bowel.

Participants will undergo the same procedures as standard care adding questionnaires and replacing water as the bowel distension agent for the MRE for patient randomized into the experimental group.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria: * Diagnosis of Crohn's Disease, * need for MRE (determined by patient's gastroenterologist) Exclusion criteria: * \< 18 years old, * inability to obtain an informed consent, * patient under guardianship or curatorship, allergy to PEG, * contraindication to MRE (pregnancy, pace maker, claustrophobia in particular), - contraindication to phloroglucinol administration (phenylcetonuria), * contraindication to gadolinium administration (kidney failure with glomerular filtration rate \< 30/mL/1.73m², pregnancy, allergy).

Primary outcome measure(s)

  • Bowel distension — The day of the Magnetic Resonance Enterography (MRE), specifically during the imaging procedure : from ingestion of distension product to end of imaging, approximately 1 hour
    Proportion of patients with an overall small bowel distension over 2 on a validated scale (from 0=poor to 4=excellent)

Trial sites (1)

FacilityCityRegionStatus
CHU Toulouse Toulouse France Recruiting

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Other trials for the same condition

Kinetics of Transmural Healing in Patients With Crohns Disease Treated With Risankizumab (SKYRIZI®) Active, not recruiting
Tolerance of Local Administration of Cryopreserved Autologous Stromal Vascular Fraction Combined With Micrograft for the Treatment of Refractory Ano-perineal Fistulas in Crohn's Disease Recruiting
Concordance Between Inflammatory Activity Assessed by Enteric MRI With and Without Intestinal Distension Product in Patients With Ileal Crohn's Disease. Recruiting
Optimal Care With Guselkumab in Crohn's Disease / OPTIM Study A Prospective Open Label Interventional, Multicenter Study Recruiting
Reliability of IUS in Crohn's Disease Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06690632 on ClinicalTrials.gov ↗ ← All trials in France