WAter Preparation in Crohn's Disease's Imagery

NCT06690632 | Recruiting

• 1 other identifier: RC31/24/0238
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn Disease (CD)

Keywords

Crohn; bowel distension; MRE; oral contrast media; tolerability

Outcome Measures

Primary Outcomes (1)

• Bowel distension

  Proportion of patients with an overall small bowel distension over 2 on a validated scale (from 0=poor to 4=excellent)

  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

Secondary Outcomes (3)

• self evaluated Tolerability of symptoms

  before MRE

• self evaluated Tolerability of symptoms

  right after MRE

• self evaluated Tolerability of symptoms

  48 hour post MRE

Study Arms (2)

WATER

EXPERIMENTAL

ingestion of 1.5L of water 30min prior MRE acquisition

Other: water preparation

PEG

ACTIVE COMPARATOR

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

Other: polyethylene glycol preparation

Interventions

water preparation OTHER

ingestion of 1.5L of water 30min prior MRE acquisition

WATER

polyethylene glycol preparation OTHER

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

PEG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Crohn's Disease,
• need for MRE (determined by patient's gastroenterologist)

You may not qualify if:

• \< 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).

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

mineral acids, trace elements, water, drug combination

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Guillaume Dr LE COSQUER, MD

CONTACT

+33 (0)5 61 32 20 45; lecosquer.g@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The exams and distension scores will be determined by two radiologists (one expert and one trainee) blinded on patient allocation group. In case of disagreement, a third radiologist (expert) will be required.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective monocentric interventional single-blinded study. Randomization with 1:1 ratio between water preparation and standard preparation after stratification on past bowel resection and structuring phenotype. The exams and distension scores will be determined by two radiologists (one expert and one trainee) blinded on patient allocation group. In case of disagreement, a third radiologist (expert) will be required.

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 15, 2024
• Study Start: January 29, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

FR (1)