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
  Purpose

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
Inflammatory Bowel Disease
Ulcerative Colitis
Irritable Bowel Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Combined Assessment of Colonic Permeability by Real Time Confocal Laser Endomicroscopy and Sucralose Absorption Test

Resource links provided by NLM:


Further study details as provided by Shandong University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Total sucralose excretion. [ Time Frame: Within the 24 hours after drinking of sucralose ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biopsies during colonoscopy.


Estimated Enrollment: 30
Study Start Date: April 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883077

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

Locations
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
Investigators
Study Director: Yanqing Li, PhD. MD. Department of Gastroenterology, Qilu Hospital, Shandong University
  More Information

No publications provided

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
Study First Received: April 15, 2009
Last Updated: October 13, 2009
Health Authority: China: Ministry of Health

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

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

ClinicalTrials.gov processed this record on August 26, 2014