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NCT Number: NCT06690632

WAter Preparation in Crohn's Disease's Imagery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Toulouse

Toulouse, France

Location status: Recruiting

Location contact

Cindy CANIVET

CONTACT

[email protected]

(+33 5 61 3)2 20 48

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

water preparation

Other

ingestion of 1.5L of water 30min prior MRE acquisition

polyethylene glycol preparation

Other

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

Primary outcomes

  1. Bowel distension

    Time frame: 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)

Secondary outcomes

  1. self evaluated Tolerability of symptoms

    Time frame: before MRE

    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"

  2. self evaluated Tolerability of symptoms

    Time frame: right after MRE

    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"

  3. self evaluated Tolerability of symptoms

    Time frame: 48 hour post MRE

    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"

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume Dr LE COSQUER, MD

CONTACT

[email protected]

+33 (0)5 61 32 20 45

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

WAter Preparation for Magnetic Resonance Enterography in Crohn's Disease

Acronym: WAM

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Nov 15, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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