Assessment of Colonic Permeability by Confocal Laser Endomicroscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of confocal laser endomicroscopy in assessment of colonic permeability against conventional sugar absorption test.

Detailed Description
-----------------
Increased intestinal permeability has been shown significant in many gastrointestinal diseases, including inflammatory bowel disease and recently irritable bowel syndrome. The conventional test methods of permeability is sugar absorption test which is neither reliable and practical. Confocal laser endomicrosopy is a newly developed device which allows in vivo and real time observation of gastrointestinal mucosa. In our preliminary study we found that the commonly used contrast agent, fluorescein sodium shew differences of leakage into colonic crypt lumen among different patients. The fluorescein leakage might be due to abnormal colonic permeability, so we planed to compare the fluorescein leakage under confocal laser endomicroscopy with conventional sucralose absorption test.

Official Title
-----------------
Combined Assessment of Colonic Permeability by Real Time Confocal Laser Endomicroscopy and Sucralose Absorption Test

Conditions
-----------------
Inflammatory Bowel Disease, Ulcerative Colitis, Irritable Bowel Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with history of ulcerative colitis Bowel habits alterations meeting IBS diagnosis criteria and indications for colonoscopy investigation Asymptomatic individuals for health surveillance or patients for follow up after polypectomy Patients complained of hemafecia but colonoscopy revealed only haemorrhoid Exclusion Criteria: Known cancers or abdominal surgery Scheduled for endoscopic treatment Alarm symptoms such as anaemia, gastrointestinal bleeding or obstruction, marked weight loss, abdominal mass Under conditions such as: ascites jaundice liver cirrhosis impaired renal function coagulopathy fever pregnancy breastfeeding Inability to provide informed consent Known allergy to fluorescein sodium

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Inflammation<br>Patients with long standing history or short onset of ulcerative colitis. | |
| Healthy controls<br>Asymptomatic individuals admitted for health surveillance or patients for follow up after polypectomy. | |
| Irritable bowel syndrome<br>Patients admitted to outpatient department with symptoms meeting ROME III criteria of irritable bowel syndrome. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluorescein leakage under confocal laser endomicroscopy observation of colonic mucosa. |  | Within the 30 minutes after injection of fluorescein | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total sucralose excretion. |  | Within the 24 hours after drinking of sucralose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
permeability, inflammatory bowel disease, confocal laser endomicroscopy, irritable bowel syndrome