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A prospective evaluation of the use of intestinal ultrasound as an assessment tool in predicting the course of intestinal inflammation and response to therapy in patients with inflammatory bowel disease

A prospective evaluation of the use of intestinal ultrasound as an assessment tool in predicting the course of intestinal inflammation and response to therapy in patients with inflammatory bowel disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621000168853
Enrollment
41
Registered
2021-02-18
Start date
2018-07-01
Completion date
2020-02-14
Last updated
2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients with inflammatory bowel disease when commencing on new medical therapy for treatment of their disease will be recruited for participation in this gastrointestinal ultrasound study. The purpose of the study is to determine if gastrointestinal ultrasound can predict who will respond to a particular medical therapy. Gastrointestinal ultrasound findings will also be compared to other routine markers of disease activity such as clinical scores and biochemical markers.

Interventions

Individuals with known inflammatory bowel disease, being commenced on new medical therapy for treatment of their disease will be prospectively recruited for observation with frequent gastrointestinal ultrasound (GIUS) to determine if GIUS can be used to predict response to therapy. Patients included will be commencing any new medical therapy including; corticosteroids, exclusive enteral nutritional, immunomodulator but a focus on recruiting those commencing 'biologics'; infliximab, adalimumab,

Individuals with known inflammatory bowel disease, being commenced on new medical therapy for treatment of their disease will be prospectively recruited for observation with frequent gastrointestinal ultrasound (GIUS) to determine if GIUS can be used to predict response to therapy. Patients included will be commencing any new medical therapy including; corticosteroids, exclusive enteral nutritional, immunomodulator but a focus on recruiting those commencing 'biologics'; infliximab, adalimumab, vedolizumab or ustekinumab. Patients will be followed up based on a biologics infusion schedule at 0, 2, 6 and 14 weeks and then 8 weekly until week 46 (total of 8 visits). All patients will be followed up on the same schedule regardless of treatment type for as long as treatment persist i.e. those on exclusive enteral nutritional (EEN) will likely only have 3 follow up visits. At each study visit two GIUS will be performed by two independent gastroenterologists, blinded to each others results. A detailed GIUS will be performed including assessment of bowel wall thickness (4 measurements per bowel segment), vascularity (graded by the Limberg score), wall stratification assessment, peristalsis (where appropriate), loss of haustration and white plaque echo (where appropriate), lymphadenopathy, mesenteric hyperechogenicity, stricture assessment (where appropriate), constipation assessment (for those with ulcerative colitis). Further assessment will occur at each study visit, including 1) blood tests for routine biochemistry and inflammatory markers and storage of serum and plasma 2) faecal calprotectin testing 3) clinical activity assessment 4) record of changes to medications and progress of disease 5) IBD quality of life questionnaire (IBDQ). At commencement, week 14 and week 46 stool microbiota will also be collected. At baseline visit routine disease and patient characteristics will be recorded. The study visit in total is expected to be a maximum of approximately 1 hour, with each ultrasound taking between 15-20 minutes for a complete examination.

Sponsors

Monash University - Central Clinical School
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. 18 years or above with a diagnosis of inflammatory bowel disease 2. Commencing new medical therapy for inflammatory bowel disease 3. Inflammatory bowel disease visible on gastrointestinal ultrasound

Exclusion criteria

1. Patients with perianal disease as the predominant problem 2. Patients with disease distribution known to be proctitis 3. Patients unable to give informed consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026