ANZCTR - Registration

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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

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

inflammatory bowel disease

Condition category

Condition code

Oral and Gastrointestinal

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The proportion of patients achieving sonographic remission or response by week 14.

Timepoint [1]

Week 14 post initiation of treatment

Secondary outcome [1]

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]

Inter-observer agreement will be assessed at Week 0 and Week 14 (end of induction).

Secondary outcome [2]

Proportion of patients with biochemically active disease, as assessed by faecal calprotectin

Timepoint [2]

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]

Proportion of patients with clinically active disease as assessed by Harvey-Bradshaw Index and Partial Mayo Score

Timepoint [3]

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]

Change in IBDQ findings over time in response to treatment

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Alfred Hospital

Address [1]

The Alfred Centre, Central Clinical School, Level 5
99 Commercial Road Melbourne VIC 3004

Country [1]

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]

Hospital

Name [1]

The Alfred Hospital

Address [1]

The Alfred Centre, Central Clinical School, Level 5
99 Commercial Road Melbourne VIC 3004

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Ethics Committee

Ethics committee address [1]

Level 5, 553 St Kilda Rd 
Melbourne VIC 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/04/2018

Approval date [1]

30/05/2018

Ethics approval number [1]

212/18

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Rebecca Smith

Address

Central Clinical School - Monash University
Level 5, 99 Commercial Road Melbourne VIC 3004

Country

Australia

Phone

+61 3 9903 0555

Fax

[email protected]

Contact person for public queries

Name

Rebecca Smith

Address

Central Clinical School - Monash University
Level 5, 99 Commercial Road Melbourne VIC 3004

Country

Australia

Phone

+61 3 9903 0555

Fax

[email protected]

Contact person for scientific queries

Name

Rebecca Smith

Address

Central Clinical School - Monash University
Level 5, 99 Commercial Road Melbourne VIC 3004

Country

Australia

Phone

+61 3 9903 0555

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
9840	Ethical 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

Source	Title	Year of Publication	DOI
Embase	Early sonographic response to a new medical therapy is associated with future treatment response or failure in patients with inflammatory bowel disease.	2022	https://dx.doi.org/10.1097/MEG.0000000000002367

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically