Trial Details

Not Recruiting
Basic Information
Clinical ID c2442
Identifier ACTRN12621000168853
Trial Title 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
Trial URL Visit Original Page
Study Information
Study Results

Yes

Conditions inflammatory bowel disease; inflammatory bowel disease;Oral and Gastrointestinal - Inflammatory bowel disease
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, 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 co
Participant Information
Sponsor Monash University - Central Clinical School
City -
Country/Region Australia
Enrollment Criteria
Sex Requirement ALL
Age Requirement ADULT, ELDER, OLDER_ADULT
Study Design
Study Type Observational
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date 2021-02-18
Completion Date 2021-01-11