Confocal endomicroscopy and leaky gut in Crohn's disease and ulcerative colitis.

Not Applicable

Recruiting

• Conditions: Crohn's disease; ulcerative colitis; Inflammatory and Immune System - Other inflammatory or immune system disorders; Oral and Gastrointestinal - Crohn's disease

• Registration Number: ACTRN12613001248752
• Lead Sponsor: Bankstown Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

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)

Exclusion Criteria

Severe flare of IBD making colonoscopy dangerous
Documented allergy to fluorescein.
Pregnancy and lactation-breast-feeding

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. [Baseline - cross sectional. ]

Secondary Outcome Measures

Name	Time	Method
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. [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.]