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Trial registered on ANZCTR


Registration number
ACTRN12621000168853
Ethics application status
Approved
Date submitted
23/11/2020
Date registered
18/02/2021
Date last updated
18/02/2021
Date data sharing statement initially provided
18/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 302846 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
inflammatory bowel disease 319826 0
Condition category
Condition code
Oral and Gastrointestinal 317766 317766 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 319130 0
Diagnosis / Prognosis
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325787 0
The proportion of patients achieving sonographic remission or response by week 14.

Timepoint [1] 325787 0
Week 14 post initiation of treatment
Secondary outcome [1] 389137 0
Assessing the inter observer agreement of gastrointestinal ultrasound findings between different operators - including: bowel wall thickness, vascularity assessment, mesenteric hyperechogenicity, wall stratification assessment and lymphadenopathy
Timepoint [1] 389137 0
Inter-observer agreement will be assessed at Week 0 and Week 14 (end of induction).
Secondary outcome [2] 390001 0
Proportion of patients with biochemically active disease, as assessed by faecal calprotectin
Timepoint [2] 390001 0
Throughout all major study time points where there is available data (Week 0, 2, 6, 14 weeks and then 8 weekly until week 46 post initiation of treatment)
Secondary outcome [3] 390002 0
Proportion of patients with clinically active disease as assessed by Harvey-Bradshaw Index and Partial Mayo Score
Timepoint [3] 390002 0
Throughout all major study time points where there is available data (Week 0, 2, 6, 14 weeks and then 8 weekly until week 46 post initiation of treatment)
Secondary outcome [4] 390003 0
Change in IBDQ findings over time in response to treatment
Timepoint [4] 390003 0
Throughout all major study time points where there is available data (Week 0, 2, 6, 14 weeks and then 8 weekly until week 46 post initiation of treatment)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/2018
Date of last participant enrolment
Anticipated
Actual
14/02/2020
Date of last data collection
Anticipated
Actual
11/01/2021
Sample size
Target
50
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18077 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 32065 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 307266 0
Hospital
Name [1] 307266 0
The Alfred Hospital
Country [1] 307266 0
Australia
Primary sponsor type
University
Name
Monash University - Central Clinical School
Address
The Alfred Centre, Central Clinical School, Level 5
99 Commercial Road Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 307890 0
Hospital
Name [1] 307890 0
The Alfred Hospital
Address [1] 307890 0
The Alfred Centre, Central Clinical School, Level 5
99 Commercial Road Melbourne VIC 3004
Country [1] 307890 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307364 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 307364 0
Ethics committee country [1] 307364 0
Australia
Date submitted for ethics approval [1] 307364 0
02/04/2018
Approval date [1] 307364 0
30/05/2018
Ethics approval number [1] 307364 0
212/18

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106970 0
Dr Rebecca Smith
Address 106970 0
Central Clinical School - Monash University
Level 5, 99 Commercial Road Melbourne VIC 3004
Country 106970 0
Australia
Phone 106970 0
+61 3 9903 0555
Fax 106970 0
Email 106970 0
re.smith@alfred.org.au
Contact person for public queries
Name 106971 0
Rebecca Smith
Address 106971 0
Central Clinical School - Monash University
Level 5, 99 Commercial Road Melbourne VIC 3004
Country 106971 0
Australia
Phone 106971 0
+61 3 9903 0555
Fax 106971 0
Email 106971 0
re.smith@alfred.org.au
Contact person for scientific queries
Name 106972 0
Rebecca Smith
Address 106972 0
Central Clinical School - Monash University
Level 5, 99 Commercial Road Melbourne VIC 3004
Country 106972 0
Australia
Phone 106972 0
+61 3 9903 0555
Fax 106972 0
Email 106972 0
re.smith@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9840Ethical approval    380978-(Uploaded-23-11-2020-13-26-48)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEarly sonographic response to a new medical therapy is associated with future treatment response or failure in patients with inflammatory bowel disease.2022https://dx.doi.org/10.1097/MEG.0000000000002367
N.B. These documents automatically identified may not have been verified by the study sponsor.