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Trial registered on ANZCTR


Registration number
ACTRN12613001248752
Ethics application status
Approved
Date submitted
7/08/2013
Date registered
13/11/2013
Date last updated
13/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Confocal endomicroscopy and leaky gut in Crohn's disease and ulcerative colitis.
Scientific title
Impaired Mucosal Epithelial Barrier Function Identified by Confocal Endomicroscopy in Crohn's Disease and Ulcerative Colitis.
Secondary ID [1] 282985 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's disease 289813 0
ulcerative colitis 289855 0
Condition category
Condition code
Inflammatory and Immune System 290161 290161 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 290162 290162 0 0
Crohn's disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Confocal endomicroscopy - an endoscopic procedure that incorporates a laser microscope on the tip of the endoscope - visualising the microscopic structure of the gut lining. The confocal laser microscope enlarges the mucosa image by 1,000-fold. The procedure is performed using standard sedation procedure. Procedure duration lasts for 15 - 30 minutes, similar to a standard colonoscopy.

Inflammatory bowel disease patients requiring colonoscopy will be invited to participate. All patients will be assessed for clinical disease activity (CDAI or Mayo), biomarkers of inflammation (ESR, CRP), medical and surgical therapy. Controls will be non-IBD patients requiring colonoscopy eg for screening for family history, minor gastrointestinal symptoms where IBD is finally excluded, Fe deficiency where an alternative diagnosis is eventually made (eg menorrhagia). All subjects undergo confocal endomicroscopy.
Intervention code [1] 287698 0
Not applicable
Comparator / control treatment
Non-IBD controls are people requiring colonoscopy with final exclusion of Crohn's disease and ulcerative colitis. Group age- and sex- matched controls will be used. Examples include patients presenting for endoscopy for investigation of Fe studies.
Control group
Active

Outcomes
Primary outcome [1] 290191 0
The primary outcome is to determine if confocal endomicroscopy identifies leaky gut in inflammatory bowel diseases compared with non-IBD controls. Confocal endomicroscopy incorporates a microscope on the tip of a conventional endoscope. The colonoscopy will be conducted as per normal practice. We will then use the laser microscope on consented patients to obtained further information on the bowel lining. Leaky gut is visualised using the high power magnification of the confocal scope but plays no part in the decision process of patient treatment, as so far we do not know what it contributes towards prediction of disease course. The amount of images demonstrating leaky gut is compared between Crohn's disease, ulcerative colitis and controls at baseline.
Timepoint [1] 290191 0
Baseline - cross sectional.
Secondary outcome [1] 304081 0
Reversibility of leaky gut with treatment will be assessed using the same confocal endomicroscopy technique. Patients requiring follow up confocal colonoscopy have have the leaky gut remeasured to determine if interval change has occurred - whether leaky gut has progressed, remained stable or worsened. This is correlated with whether treatment escalation was required. Only standard treatment for IBD as deemed clinically required will be administered. Confocal endomicroscopy will play no role in deciding whether treatment is to be changed.
Timepoint [1] 304081 0
Indefinite: patients are invited to return to have repeat confocal endomicroscopy to determine reversibility of leaky gut. Typically, chronic patients require yearly colonoscopy to exclude the development of cancers - hence this protocol may be incorporated into these patients for their return procedures. Others require less frequent colonoscopy - eg only if they flare or require a follow up to demonstrate healing after changing their treatments.

Eligibility
Key inclusion criteria
Patients requiring colonoscopy and consenting to the confocal colonoscopy study will be recruited.
Age 16 - 80
Males and females
Known IBD and non-IBD controls (eg those investigated for iron deficiency but shows no changes of IBD on colonoscopy)
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe flare of IBD making colonoscopy dangerous
Documented allergy to fluorescein.
Pregnancy and lactation-breast-feeding

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Patients have confocal endomicroscopy to detect leaky gut. We follow them up to determine whether leaky gut results in the need for treatment escalation. If repeat confocal endomicroscopy is performed after treatment escalation, we determine if their leaky gut is reversed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/11/2011
Actual
29/11/2011
Date of last participant enrolment
Anticipated
31/12/2014
Actual
27/08/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1427 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment postcode(s) [1] 7261 0
2200 - Bankstown

Funding & Sponsors
Funding source category [1] 287759 0
Hospital
Name [1] 287759 0
Bankstown Hospital
Country [1] 287759 0
Australia
Primary sponsor type
Hospital
Name
Bankstown Hospital
Address
Bankstown Hospital
Department of Gastroenterology
Level 3
Eldridge Rd
Bankstown NSW 2200
Country
Australia
Secondary sponsor category [1] 286485 0
University
Name [1] 286485 0
University of New South Wales
Address [1] 286485 0
UNSW South Western Sydney Clinical School
Bankstown Hospital
Dept of Gastroenterology
Level 3
Eldridge Rd
Bankstown NSW 2200
Country [1] 286485 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289706 0
South Western Sydney Local Health District
Ethics committee address [1] 289706 0
Ethics committee country [1] 289706 0
Australia
Date submitted for ethics approval [1] 289706 0
01/07/2011
Approval date [1] 289706 0
08/10/2011
Ethics approval number [1] 289706 0
HREC/10/LPOOL/115

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

Contacts
Principal investigator
Name 42050 0
Prof Rupert Leong
Address 42050 0
Bankstown Hospital
Dept of Gastroenterology
Level 3
Eldridge Rd
Bankstown NSW 2200
Country 42050 0
Australia
Phone 42050 0
61297228794
Fax 42050 0
61297227752
Email 42050 0
[email protected]
Contact person for public queries
Name 42051 0
Rupert Leong
Address 42051 0
Bankstown Hospital
Dept of Gastroenterology
Level 3
Eldridge Rd
Bankstown NSW 2200
Country 42051 0
Australia
Phone 42051 0
61297228794
Fax 42051 0
Email 42051 0
[email protected]
Contact person for scientific queries
Name 42052 0
Rupert Leong
Address 42052 0
Bankstown Hospital
Dept of Gastroenterology
Level 3
Eldridge Rd
Bankstown NSW 2200
Country 42052 0
Australia
Phone 42052 0
61297228794
Fax 42052 0
Email 42052 0
[email protected]

No information has been provided regarding IPD availability


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.