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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
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

Study type
Patient registry
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

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.

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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Severe flare of IBD making colonoscopy dangerous
Documented allergy to fluorescein.
Pregnancy and lactation-breast-feeding

Study design
Natural history
Convenience sample
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 status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
Name [1] 287759 0
Bankstown Hospital
Address [1] 287759 0
Bankstown Hospital
Department of Gastroenterology
Level 3
Eldridge Rd
Bankstown NSW 2200
Country [1] 287759 0
Primary sponsor type
Bankstown Hospital
Bankstown Hospital
Department of Gastroenterology
Level 3
Eldridge Rd
Bankstown NSW 2200
Secondary sponsor category [1] 286485 0
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

Ethics approval
Ethics application status
Ethics committee name [1] 289706 0
South Western Sydney Local Health District
Ethics committee address [1] 289706 0
Locked Bag 7017, Liverpool BC, NSW 1871
Ethics committee country [1] 289706 0
Date submitted for ethics approval [1] 289706 0
Approval date [1] 289706 0
Ethics approval number [1] 289706 0

Brief summary
Leaky gut is a possible precipitant of inflammatory bowel diseases. We determine whether leaky gut can be identified in patients with Crohn's disease and ulcerative colitis in comparison with non-IBD controls using confocal endomicroscopy, which can identify microscopic barrier function of the bowel mucosa. Patients are followed longitudinally to determine if they improve or flare requiring treatment escalation.
Trial website
Trial related presentations / publications
Public notes

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
Phone 42050 0
Fax 42050 0
Email 42050 0
Contact person for public queries
Name 42051 0
Prof Rupert Leong
Address 42051 0
Bankstown Hospital
Dept of Gastroenterology
Level 3
Eldridge Rd
Bankstown NSW 2200
Country 42051 0
Phone 42051 0
Fax 42051 0
Email 42051 0
Contact person for scientific queries
Name 42052 0
Prof Rupert Leong
Address 42052 0
Bankstown Hospital
Dept of Gastroenterology
Level 3
Eldridge Rd
Bankstown NSW 2200
Country 42052 0
Phone 42052 0
Fax 42052 0
Email 42052 0

No information has been provided regarding IPD availability
Summary results
No Results