Assessment of Colonic Permeability by Confocal Laser Endomicroscopy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Shandong University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shandong University
ClinicalTrials.gov Identifier:
NCT00883077
First received: April 15, 2009
Last updated: October 13, 2009
Last verified: October 2009

April 15, 2009
October 13, 2009
April 2009
November 2009   (final data collection date for primary outcome measure)
Fluorescein leakage under confocal laser endomicroscopy observation of colonic mucosa. [ Time Frame: Within the 30 minutes after injection of fluorescein ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00883077 on ClinicalTrials.gov Archive Site
Total sucralose excretion. [ Time Frame: Within the 24 hours after drinking of sucralose ] [ Designated as safety issue: No ]
Total sucralose excretion. [ Time Frame: With the 24 hours after drinking of sucralose. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Assessment of Colonic Permeability by Confocal Laser Endomicroscopy
Combined Assessment of Colonic Permeability by Real Time Confocal Laser Endomicroscopy and Sucralose Absorption Test

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

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Biopsies during colonoscopy.

Non-Probability Sample

Patients with indications for colonoscopy in Qilu Hospital outpatient and inpatient department are the study population of this study.

  • Inflammatory Bowel Disease
  • Ulcerative Colitis
  • Irritable Bowel Syndrome
Not Provided
  • Inflammation
    Patients with long standing history or short onset of ulcerative colitis.
  • Healthy controls
    Asymptomatic individuals admitted for health surveillance or patients for follow up after polypectomy.
  • Irritable bowel syndrome
    Patients admitted to outpatient department with symptoms meeting ROME III criteria of irritable bowel syndrome.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact: Yanqing Li, PhD. MD. 86-531-8216923 ext 82169508 qiluliyanqign@gmail.com
China
 
NCT00883077
2009SDU-QILU-G01
Yes
Yan-Qing Li, Department of Gastroenterology, Qilu Hospital, Shandong University
Shandong University
Not Provided
Study Director: Yanqing Li, PhD. MD. Department of Gastroenterology, Qilu Hospital, Shandong University
Shandong University
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP