Crohn Disease (CD)WAMNCT06690632
WAter Preparation in Crohn's Disease's Imagery
A study testing water preparation and polyethylene glycol preparation in people with Crohn Disease (CD), run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease (CD)
- What is being tested?
- water preparation and polyethylene glycol preparation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jan 2025to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Crohn's Disease,
- need for MRE (determined by patient's gastroenterologist)
Who cannot join
- < 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Toulouse
Toulouse
Cindy CANIVET, (+33 5 61 3)2 20 48, canivet.c@chu-toulouse.fr
About this study
Official title: 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:
Read more
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.
Read the 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).
- Conditions
- Crohn Disease (CD)
- Being tested
- water preparation, polyethylene glycol preparation
- Keywords
- Crohn, bowel distension, MRE, oral contrast media, tolerability
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water preparationOther
ingestion of 1.5L of water 30min prior MRE acquisition
polyethylene glycol preparationOther
ingestion of 1.5L of water diluted PEG 45 min prior MRE acquisition (standard protocol)
| Study group | Role | What they receive |
|---|---|---|
| WATER | Experimental | ingestion of 1.5L of water 30min prior MRE acquisition Receives: Other: water preparation |
| PEG | Active comparator | ingestion of 1.5L of water diluted PEG 45 min prior MRE acquisition (standard protocol) Receives: Other: polyethylene glycol preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel distension
Proportion of patients with an overall small bowel distension over 2 on a validated scale (from 0=poor to 4=excellent)
Measured: 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
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"
Measured: 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"
Measured: 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"
Measured: 48 hour post MRE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start29 Jan 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690632
- Sponsor's protocol ID
- RC31/24/0238
- Acronym
- WAM
- Status last verified
- May 2026
- First submitted
- 29 Oct 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WAter Preparation for Magnetic Resonance Enterography in Crohn's Disease
- ClinicalTrials.gov ID
- NCT06690632
- Acronym / sponsor ID
- WAM / RC31/24/0238
- Conditions
- Crohn Disease (CD)
- Keywords
- Crohn, bowel distension, MRE, oral contrast media, tolerability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| WATER | Experimental | Other: water preparationingestion of 1.5L of water 30min prior MRE acquisition |
| PEG | Active comparator | Other: polyethylene glycol preparationingestion of 1.5L of water diluted PEG 45 min prior MRE acquisition (standard protocol) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Crohn's Disease,
- need for MRE (determined by patient's gastroenterologist)
Key exclusion criteria (5 listed)
- < 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| water preparationingestion of 1.5L of water 30min prior MRE acquisition | Other | WATER |
| polyethylene glycol preparationingestion of 1.5L of water diluted PEG 45 min prior MRE acquisition (standard protocol) | Other | PEG |
Primary outcome
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)
3 secondary outcomes
self evaluated Tolerability of symptoms
Time frame: before MRE
self evaluated Tolerability of symptoms
Time frame: right after MRE
self evaluated Tolerability of symptoms
Time frame: 48 hour post MRE
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing water preparation and polyethylene glycol preparation in people with Crohn Disease (CD), run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Dr LE COSQUER, MD (+33 (0)5 61 32 20 45, lecosquer.g@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.