WAter Preparation in Crohn's Disease's Imagery
ConditionCrohn Disease (CD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of Crohn's Disease,
need for MRE (determined by patient's gastroenterologist)
Disqualifiers
< 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),
Trial design
Design model
Parallel
Treatments tested in this trial
water preparation
Other interventioningestion of 1.5L of water 30min prior MRE acquisition
polyethylene glycol preparation
Other interventioningestion of 1.5L of water diluted PEG 45 min prior MRE acquisition (standard protocol)
Treatment groups
194 Participants
are divided into 2 treatment groupsGroup A: WATERExperimental treatment 1 intervention
Group B: PEGActive comparator 1 intervention
Trial outcomes
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)
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 hourSecondary outcomes
1
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"
Time frame
before MRE2
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"
Time frame
right after MRE3
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"
Time frame
48 hour post MRESponsors and contacts
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Source ClinicalTrials.gov