We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Assessment of Colonic Permeability by Confocal Laser Endomicroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00883077
Recruitment Status : Unknown
Verified October 2009 by Shandong University.
Recruitment status was:  Recruiting
First Posted : April 17, 2009
Last Update Posted : October 14, 2009
Information provided by:
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.

Condition or disease
Inflammatory Bowel Disease Ulcerative Colitis Irritable Bowel Syndrome

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 Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Combined Assessment of Colonic Permeability by Real Time Confocal Laser Endomicroscopy and Sucralose Absorption Test
Study Start Date : April 2009
Estimated Primary Completion Date : November 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Fluorescein leakage under confocal laser endomicroscopy observation of colonic mucosa. [ Time Frame: Within the 30 minutes after injection of fluorescein ]

Secondary Outcome Measures :
  1. Total sucralose excretion. [ Time Frame: Within the 24 hours after drinking of sucralose ]

Biospecimen Retention:   Samples With DNA
Biopsies during colonoscopy.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883077

Contact: Yanqing Li, PhD. MD. 86-531-8216923 ext 82169508 qiluliyanqign@gmail.com

China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Yanqing Li, PhD. MD.    86-531-82169236 ext 82169508    qiluliyanqing@gmail.com   
Principal Investigator: Yanqing Li, PhD. MD.         
Sub-Investigator: Changqing Li, PhD.         
Sponsors and Collaborators
Shandong University
Study Director: Yanqing Li, PhD. MD. Department of Gastroenterology, Qilu Hospital, Shandong University

Responsible Party: Yan-Qing Li, Department of Gastroenterology, Qilu Hospital, Shandong University
ClinicalTrials.gov Identifier: NCT00883077     History of Changes
Other Study ID Numbers: 2009SDU-QILU-G01
First Posted: April 17, 2009    Key Record Dates
Last Update Posted: October 14, 2009
Last Verified: October 2009

Keywords provided by Shandong University:
inflammatory bowel disease
confocal laser endomicroscopy
irritable bowel syndrome

Additional relevant MeSH terms:
Colitis, Ulcerative
Irritable Bowel Syndrome
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Colonic Diseases, Functional