Crohn Disease (CD)NCT07079007
Use of Water Ingestion in Small Intestine Ultrasound
An observational study of Crohn Disease (CD) and Intestine Ultrasonography, run by Austin Health at 1 site in Australia.
Trial summary
Small Intestine Contrast Ultrasonography (SICUS) is an ultrasound-based method that explores bowel loops, and is able to identify wall thickness, intestinal motility, bowel wall vascularity and complications such as stenosis or dilatation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn Disease (CD), Intestine Ultrasonography
- What is being tested?
- Water
- How many people
- 55 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2025to Feb 2026
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients already referred and scheduled to undertake an IUS in the single-centre Austin Health IUS clinic would undergo a baseline procedure. Patients that meet the inclusion and exclusion criteria would be asked to ingest 1000ml water as part of standard of care.
Who may be able to join
- All consecutive patients at baseline scan with:
- Confirmed or suspected Crohn's disease with small bowel involvement
- Increased bowel wall thickness (>3mm) of the terminal ileum
- Suboptimal luminal distension of the terminal ileum 3cm proximal to ICV and 1cm proximal to diseased segment (defined as <8mm)
- All patients with an ileo-colic anastomosis
Who cannot join
- Presence of an ostomy
- Adequate distension at baseline scan
- Patients with ileo-rectal anastomosis or IPAA
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Austin Health
Heidelberg, Victoria, 3084
Sheng Wei Lo, +61 3 94965000, shengwei.lo@austin.org.au
About this study
Official title: Use of Water Ingestion to Improve Visualisation in Small Intestine Ultrasound (WIVIUS): Single Centre Blinded Crossover Trial
Small Intestine Contrast Ultrasonography (SICUS) is an ultrasound-based method that explores bowel loops, and is able to identify wall thickness, intestinal motility, bowel wall vascularity and complications such as stenosis or dilatation. Previous studies have utilised oral ingestion of an oral contrast solution (usually PEG dissolved in a volume of water ranging from 250 to 1000mL), in order to increase the sensitivity of ultrasound, especially in stricture detection. Parameters that have been improved include lumen distension to better delineate bowel wall layers, and improved peristalsis. Diffusion of this technique has been limited, in part due to PEG-based agents being costly, time consuming and are not tolerated well in some individuals. Utilisation of water as oral contrast may improve patient tolerability and therefore increase uptake of water ingested intestinal contrast ultrasound (WICUS) as a technique in routine clinical practice. The investigators aim to study the tolerability and the improvement of image quality utilising water as an oral contrast for intestinal ultrasonography.
- Conditions
- Crohn Disease (CD), Intestine Ultrasonography
- Being tested
- Water
- Keywords
- small bowel contrast ultrasound
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaterOther
Patients that meet the inclusion and exclusion criteria would be asked to ingest 1000ml water as part of standard of care.
| Study group | Role | What they receive |
|---|---|---|
| IUS oral contrast | All patients already referred and scheduled to undertake an IUS in the single-centre IUS clinic would undergo a baseline procedure. Patients that meet the inclusion and exclusion criteria would be asked to ingest 1000ml water as part of standard of care.
Inclusion Criteria
All consecutive patients at baseline scan with:
Confirmed or suspected Crohn's disease with small bowel involvement Increased bowel wall thickness (>3mm) of the terminal ileum Suboptimal luminal distension of the terminal ileum 3cm proximal to ICV and 1cm proximal to diseased segment (defined as <8mm) All patients with an ileo-colic anastomosis
Exclusion Criteria
Presence of an ostomy Adequate distension at baseline scan Patients with ileo-rectal anastomosis or IPAA Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of luminal distension of the terminal ileum
Improvement of luminal distension of the terminal ileum, defined as increase of 20% over baseline luminal diameter at the terminal ileum if no disease, taking the average as measured at 1cm intervals over 3cm of the TI in longitudinal view. If diseased segment is present, then measurements would be done at 1cm intervals over 3cm proximal to the diseased segments.
Measured: At the post-water ingestion scan 20-30 minutes after ingestion
Secondary outcomes (1)
Is image quality and visualisation of the terminal/distal ileum improved post water ingestion during intestinal ultrasound compared to baseline as assessed by blinded sonographers
Recordings of the IUS would be recorded and de-identified
Pre-contrast Cineloop x 1 of 10second duration encompassing the caecum, ileocaecal valce, terminal ileum extending to distal ileum
Post-contrast Cineloop x 1 of 10second duration encompassing the caecum, ileocaecal valce, terminal ileum extending to distal ileum
De-identified cineloops will then be randomised in a paired fashion (2 x cineloops baseline and 2 x cineloops post-contrast), and 3 external blinded sonographers will then be invited to review the cineloops - no limitation to number of times - and complete a questionnaire.
Based on before and after CINE look in random order Global (overall image) assessment. Options: Better / Unchaged / Worse of CINEloop 1 compared to CINEloop 2
Measured: At the time of post-water ingestion scan 20-30 minutes after ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionFeb 2026 (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.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Austin Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sheng Wei Lo, Austin Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079007
- Sponsor's protocol ID
- HREC/25015/Austin-2025
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Water Ingestion to Improve Visualisation in Small Intestine Ultrasound (WIVIUS): Single Centre Blinded Crossover Trial
- ClinicalTrials.gov ID
- NCT07079007
- Acronym / sponsor ID
- HREC/25015/Austin-2025
- Conditions
- Crohn Disease (CD), Intestine Ultrasonography
- Keywords
- small bowel contrast ultrasound
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Austin HealthOther government
- Study start
- Jul 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 22 Jul 2025 (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.
Small Intestine Contrast Ultrasonography (SICUS) is an ultrasound-based method that explores bowel loops, and is able to identify wall thickness, intestinal motility, bowel wall vascularity and complications such as stenosis or dilatation. Previous studies have utilised oral ingestion of an oral contrast solution (usually PEG dissolved in a volume of water ranging from 250 to 1000mL), in order to increase the sensitivity of ultrasound, especially in stricture detection. Parameters that have been improved include lumen distension to better delineate bowel wall layers, and improved peristalsis. Diffusion of this technique has been limited, in part due to PEG-based agents being costly, time consuming and are not tolerated well in some individuals. Utilisation of water as oral contrast may improve patient tolerability and therefore increase uptake of water ingested intestinal contrast ultrasound (WICUS) as a technique in routine clinical practice. The investigators aim to study the tolerability and the improvement of image quality utilising water as an oral contrast for intestinal ultrasonography.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IUS oral contrast | – | Other: WaterAll patients already referred and scheduled to undertake an IUS in the single-centre IUS clinic would undergo a baseline procedure. Patients that meet the inclusion and exclusion criteria would be asked to ingest 1000ml water as part of standard of care. Inclusion Criteria All consecutive patients at baseline scan with: Confirmed or suspected Crohn's disease with small bowel involvement Increased bowel wall thickness (>3mm) of the terminal ileum Suboptimal luminal distension of the terminal ileum 3cm proximal to ICV and 1cm proximal to diseased segment (defined as <8mm) All patients with an ileo-colic anastomosis Exclusion Criteria Presence of an ostomy Adequate distension at baseline scan Patients with ileo-rectal anastomosis or IPAA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients already referred and scheduled to undertake an IUS in the single-centre Austin Health IUS clinic would undergo a baseline procedure. Patients that meet the inclusion and exclusion criteria would be asked to ingest 1000ml water as part of standard of care.
Key inclusion criteria (5 listed)
- Confirmed or suspected Crohn's disease with small bowel involvement
- Increased bowel wall thickness (>3mm) of the terminal ileum
- Suboptimal luminal distension of the terminal ileum 3cm proximal to ICV and 1cm proximal to diseased segment (defined as <8mm)
- All patients with an ileo-colic anastomosis
Key exclusion criteria (3 listed)
- Presence of an ostomy
- Adequate distension at baseline scan
- Patients with ileo-rectal anastomosis or IPAA
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 |
|---|---|---|
| WaterPatients that meet the inclusion and exclusion criteria would be asked to ingest 1000ml water as part of standard of care. | Other | IUS oral contrast |
Primary outcome
Improvement of luminal distension of the terminal ileum
Time frame: At the post-water ingestion scan 20-30 minutes after ingestion
Improvement of luminal distension of the terminal ileum, defined as increase of 20% over baseline luminal diameter at the terminal ileum if no disease, taking the average as measured at 1cm intervals over 3cm of the TI in longitudinal view. If diseased segment is present, then measurements would be done at 1cm intervals over 3cm proximal to the diseased segments.
1 secondary outcome
Is image quality and visualisation of the terminal/distal ileum improved post water ingestion during intestinal ultrasound compared to baseline as assessed by blinded sonographers
Time frame: At the time of post-water ingestion scan 20-30 minutes after ingestion
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 22 Jul 2025.
- Individual participant dataSharing planned: No
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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?
An observational study of Crohn Disease (CD) and Intestine Ultrasonography, run by Austin Health at 1 site in Australia.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 22 Jul 2025. 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 Australia. 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 Sheng Wei Lo, MBBS (+61 3 94965000, shengwei.lo@austin.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of luminal distension of the terminal ileum (time frame: At the post-water ingestion scan 20-30 minutes after ingestion). 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 22 Jul 2025.