Assessment of Colonic Permeability by Confocal Laser Endomicroscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-12-31

Brief Summary

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The purpose of this study is to evaluate the efficacy of confocal laser endomicroscopy in assessment of colonic permeability against conventional sugar absorption test.

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Detailed Description

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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.

Conditions

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Inflammatory Bowel Disease Ulcerative Colitis Irritable Bowel Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Inflammation

Patients with long standing history or short onset of ulcerative colitis.

No interventions assigned to this group

Healthy controls

Asymptomatic individuals admitted for health surveillance or patients for follow up after polypectomy.

No interventions assigned to this group

Irritable bowel syndrome

Patients admitted to outpatient department with symptoms meeting ROME III criteria of irritable bowel syndrome.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes