Assessment of Colonic Permeability by Confocal Laser Endomicroscopy

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00883077
• Other study ID #: 2009SDU-QILU-G01
• Status: Recruiting
• Phase: N/A
• First received: April 15, 2009
• Last updated: October 13, 2009
• Start date: April 2009
• Est. completion date: December 2009

Study information

• Verified date: October 2009
• Source: Shandong University
• Contact: Yanqing Li, PhD. MD.
• Phone: 86-531-8216923
• Email: qiluliyanqign[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Irritable Bowel Syndrome
• Ulcerative Colitis

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluorescein leakage under confocal laser endomicroscopy observation of colonic mucosa.		Within the 30 minutes after injection of fluorescein	No
Secondary	Total sucralose excretion.		Within the 24 hours after drinking of sucralose	No