Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000940178
Ethics application status
Approved
Date submitted
18/06/2019
Date registered
5/07/2019
Date last updated
17/12/2021
Date data sharing statement initially provided
5/07/2019
Date results information initially provided
17/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Detection of Mycobacterium avium ssp paratuberculosis (MAP) forms in patients with Crohn’s disease and controls”- a prospective clinical study
Scientific title
Detection of Mycobacterium avium ssp paratuberculosis (MAP) forms in patients with Crohn’s disease and controls”- a prospective clinical study
Secondary ID [1] 298192 0
Nil known
Universal Trial Number (UTN)
U1111-1233-2254
Trial acronym
MAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 312775 0
Condition category
Condition code
Oral and Gastrointestinal 311277 311277 0 0
Crohn's disease
Infection 311878 311878 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Detection of Mycobacterium avium ssp paratuberculosis (MAP) forms in patients with Crohn’s disease and controls. At the screening visit consent will be obtained and a blood sample will be taken to test MAP from the participants. This study will continue for 2 years. If the study subject is a participant with Crohn’s disease the length of his/her participation will be 52 weeks. If the study subject is a participant in the control group, the length of participation will be less than one week.
Intervention code [1] 314425 0
Early Detection / Screening
Comparator / control treatment
Compare Mycobacterium avium ssp paratuberculosis forms in blood in 40 patients with Crohn’s disease (diagnosed or suspected CD) and 40 controls (no inflammatory bowel disease or irritable bowel syndrome,
Control group
Active

Outcomes
Primary outcome [1] 320018 0
Prevalence of MAP in patients with Crohn’s disease compared to controls using blood culture and specific cell-staining techniques..
Timepoint [1] 320018 0
Crohn's patients will be followed up 12-month.
Secondary outcome [1] 370259 0
Detection of MAP blood culture using cell-staining method.
Timepoint [1] 370259 0
Followed up at 3 months and 12 months post blood test.

Eligibility
Key inclusion criteria
• Test group: 40 patients diagnosed with CD or suspected to be diagnosed with CD.
• Controls: 40 patients (no inflammatory bowel disease, no irritable bowel syndrome, no pathology in the terminal ileum) who are referred to the CDD for a routine colonoscopy due to family history of bowel cancer or polyps or similar reason. These participants are ‘normal’ from the point of view of Crohn’s disease which will be excluded on colonoscopy from examination of the terminal ileum. If “a patient in the control group” is diagnosed as having Crohn’s disease in the screening period, the participant will still be included in the test group.
• Provide written informed consent to participate as shown by a signature on the consent form.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Consent not obtained.
• Any contraindications for drug/test – Vaccinated BCG, taking Infliximab or Anti-MAP therapy
• Clinical evidence of any disease which might interfere with the patient’s ability to enter the trial.
• Unable to communicate well with the investigators and to comply with the study requirements.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be conducted for CDAI, Harvey-Bradshaw index, QOL and MAP results. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) will be calculated for MAP results based on the generated sample size. Correlations will be conducted between CDAI, Harvey-Bradshaw, QOL, histopathology, stool test and MAP test results. Independent t-test or equivalent tests will be conducted to compare CDAI, Harvey Bradshaw Index, QOL, stool test and MAP results between CD and controls. Paired t-test or equivalent test will be used to assess differences in CDAI, Harvey-Bradshaw Index, QOL, stool test and MAP results between patients with CD at two time points (pre and post Anti-MAP treatment). Statistical significance will be set at 5%.


Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
8/07/2019
Actual
16/07/2019
Date of last participant enrolment
Anticipated
1/11/2021
Actual
1/11/2021
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
80
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13723 0
Centre for Digestive Diseases - Five Dock
Recruitment postcode(s) [1] 26466 0
2046 - Five Dock

Funding & Sponsors
Funding source category [1] 302733 0
Commercial sector/Industry
Name [1] 302733 0
Axent Medical
Country [1] 302733 0
Australia
Primary sponsor type
Hospital
Name
Centre for Digestive Diseases
Address
Level 1, 229 Great North Road, Five Dock, New South Wales, 2046.
Country
Australia
Secondary sponsor category [1] 302666 0
None
Name [1] 302666 0
Address [1] 302666 0
Country [1] 302666 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303338 0
Centre for Digestive Disease Ethics Committee
Ethics committee address [1] 303338 0
Level 1
229, Great North Road, Five Dock, NSW. 2046
Ethics committee country [1] 303338 0
Australia
Date submitted for ethics approval [1] 303338 0
24/04/2019
Approval date [1] 303338 0
17/06/2019
Ethics approval number [1] 303338 0
CDD18/CO3

Summary
Brief summary
This study is a single-centre, single-blind, prospective clinical trial evaluating the effect of a new diagnostic test for discrimination of CD and controls. We hypothesised that Mycobacterium avium subspecies paratuberculosis (MAP) is the leading infectious cause for CD. Therefore, developing a simple diagnostic test for MAP detection is worthy of investigation for diagnosis of CD and determining success of anti-mycobacterial therapy in patients with CD. The results of the study will provide evidence for the association between MAP and CD as well as establishing an affordable, less invasive, accurate and efficient diagnostic test for CD and/or monitoring.’
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93326 0
Prof Thomas Julius Borody
Address 93326 0
Centre for Digestive Diseases,
Level 1, 229 Great North Road, Five Dock, NSW, 2046.
Country 93326 0
Australia
Phone 93326 0
+61297134011
Fax 93326 0
+61297121675
Email 93326 0
[email protected]
Contact person for public queries
Name 93327 0
Dr Annabel Clancy
Address 93327 0
Centre for Digestive Diseases,
Level 1, 229 Great North Road, Five Dock, NSW, 2046.
Country 93327 0
Australia
Phone 93327 0
+61293700012
Fax 93327 0
+61297121675
Email 93327 0
[email protected]
Contact person for scientific queries
Name 93328 0
Dr Annabel Clancy
Address 93328 0
Centre for Digestive Diseases,
Level 1, 229 Great North Road, Five Dock, NSW, 2046.
Country 93328 0
Australia
Phone 93328 0
+61293700012
Fax 93328 0
+61297121675
Email 93328 0
[email protected]

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?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.