None listed
Conditions
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, 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
Eligibility
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