Assessment of Colonic Permeability by Confocal Laser Endomicroscopy

• Conditions: Ulcerative Colitis; Irritable Bowel Syndrome; Inflammatory Bowel Disease

• Registration Number: NCT00883077
• Lead Sponsor: Shandong University

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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-15
• Study First Submitted QC: 2009-04-15
• Study First Posted: 2009-04-17
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-13
• Last Update Posted: 2009-10-14
• Primary Completion: 2009-11
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fluorescein leakage under confocal laser endomicroscopy observation of colonic mucosa.	Within the 30 minutes after injection of fluorescein

Secondary Outcome Measures

Name	Time	Method
Total sucralose excretion.	Within the 24 hours after drinking of sucralose

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China