Clinical trial NCT00883077: Assessment of Colonic Permeability by Confocal Laser Endomicroscopy
Official title: Combined Assessment of Colonic Permeability by Real Time Confocal Laser Endomicroscopy and Sucralose Absorption Test
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Disease
Ulcerative Colitis
Irritable Bowel Syndrome
Keywords: permeability
inflammatory bowel disease
confocal laser endomicroscopy
irritable bowel syndrome
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2009-04-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with indications for colonoscopy in Qilu Hospital outpatient and inpatient department are the study population of this study.

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.

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

Primary outcomes:
measure: Fluorescein leakage under confocal laser endomicroscopy observation of colonic mucosa.
timeFrame: Within the 30 minutes after injection of fluorescein
Secondary outcomes:
measure: Total sucralose excretion.
timeFrame: Within the 24 hours after drinking of sucralose
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Department of Gastroenterology, Qilu Hospital, Shandong University
name: Yanqing Li, PhD. MD.
role: STUDY_DIRECTOR
References: