Use of Water Ingestion in Small Intestine Ultrasound

NCT07079007 | Not Yet Recruiting

• 1 other identifier: HREC/25015/Austin-2025
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

small bowel contrast ultrasound

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  At the time of post-water ingestion scan 20-30 minutes after ingestion

Other Outcomes (9)

• Grade of peristalsis

  At the time of post-water ingestion scan 20-30 mins after ingestion

• Identification of suspected stricture

  At the post-water ingestion scan 20-30 minutes after ingestion

• Measurement of bowel wall thickness

  At the post-water ingestion scan 20-30 minutes after ingestion

Study Arms (1)

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

Other: Water

Interventions

Water OTHER

Patients that meet the inclusion and exclusion criteria would be asked to ingest 1000ml water as part of standard of care.

IUS oral contrast

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Presence of an ostomy
• Adequate distension at baseline scan
• Patients with ileo-rectal anastomosis or IPAA

Sponsors & Collaborators

• Austin Health: lead

Study Sites (1)

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Water

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Central Study Contacts

Sheng Wei Lo, MBBS

CONTACT

+61 3 94965000; shengwei.lo@austin.org.au

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator: Julien Schulberg, MBBS, PhD , Austin Health, Melbourne

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 22, 2025
• Study Start: July 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: February 1, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)