WAter Preparation in Crohn's Disease's Imagery (WAM)

WAter Preparation for Magnetic Resonance Enterography in Crohn's Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease (CD)
• Intervention / Treatment: Other: water preparation; Other: polyethylene glycol preparation

Detailed Description

Magnetic Resonance Enterography (MRE) is a key tool for clinicians managing patients with Crohn's disease. This exam has a high performance in the diagnosis of complications and determination of healing rate after medical treatment. Small bowel distension with 1-1.5L of distension agent is mandatory to allow an accurate analysis of disease activity. Indeed, an insufficient distension can lead to false positive (thickened appearance of the collapsed digestive tract). Nowadays, there no consensus on the agent used for bowel distension (polyethylene glycol (PEG), lactulose, mannitol, sorbitol). The major limitation of those agent is their sides effects (e.g. diarrhea, gas bloating, vomiting) that decrease patient adherence to treatment. Some have suggested use of water as distension agent because of its price and its low side effect incidence. Yet its utilization has been limited by the fear of early absorption that may limit bowel analysis.

The aim of our study is to compare standard protocol (polyethylene glycol) with water as bowel distension agent in IBD patients requiring MRE on their ability to obtain a satisfying global distension of small bowel (on a previously validated scale).

Due to the side effects linked to the ingestion of 1.5L of distension agent and the impossibility of evaluating the tolerance of each contrast agent if 2 MREs are carried out on the same day, each the participant will benefit from an MRI using a single preparation modality (water or PEG).

To ensure comparability of the groups, patients will be randomized with 1:1 ratio 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. Regarding side effects, patient will fulfill several questionnaires after the exam and at 48h (end of follow-up).

• Study Type: Interventional
• Enrollment (Estimated): 194
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guillaume Dr LE COSQUER, MD; Phone Number: +33 (0)5 61 32 20 45; Email: lecosquer.g@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France
    • Recruiting
    • CHU Toulouse
    • Contact: Cindy CANIVET; Phone Number: (+33 5 61 3)2 20 48; Email: canivet.c@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WATER; ingestion of 1.5L of water 30min prior MRE acquisition	Other: water preparation; ingestion of 1.5L of water 30min prior MRE acquisition
Active Comparator: PEG; ingestion of 1.5L of water diluted PEG 45 min prior MRE acquisition (standard protocol)	Other: polyethylene glycol preparation; ingestion of 1.5L of water diluted PEG 45 min prior MRE acquisition (standard protocol)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
self evaluated Tolerability of symptoms	Patient's symptoms using a self-questionnaire. The questionnaire have 7 symptoms detailed and the patient indicates if the symptom is either : "Very bearable" "Moderately bearable" "Slightly bearable" "Not at all bearable" "I have not had this symptom"	before MRE
self evaluated Tolerability of symptoms	Patient's symptoms using a self-questionnaire. The questionnaire have 7 symptoms detailed and the patient indicates if the symptom is either : "Very bearable" "Moderately bearable" "Slightly bearable" "Not at all bearable" "I have not had this symptom"	right after MRE
self evaluated Tolerability of symptoms	Patient's symptoms using a self-questionnaire. The questionnaire have 7 symptoms detailed and the patient indicates if the symptom is either : "Very bearable" "Moderately bearable" "Slightly bearable" "Not at all bearable" "I have not had this symptom"	48 hour post MRE

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: tolerability; MRE; Crohn; bowel distension; oral contrast media
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; mineral acids, trace elements, water, drug combination
• Other Study ID Numbers: RC31/24/0238

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No