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Assessment of Colonic Permeability by Confocal Laser Endomicroscopy

S

Shandong University

Status

Unknown

Conditions

Irritable Bowel Syndrome
Inflammatory Bowel Disease
Ulcerative Colitis

Study type

Observational

Funder types

Other

Identifiers

NCT00883077
2009SDU-QILU-G01

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

30 participants in 3 patient groups

Inflammation
Description:
Patients with long standing history or short onset of ulcerative colitis.
Healthy controls
Description:
Asymptomatic individuals admitted for health surveillance or patients for follow up after polypectomy.
Irritable bowel syndrome
Description:
Patients admitted to outpatient department with symptoms meeting ROME III criteria of irritable bowel syndrome.

Trial contacts and locations

1

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Central trial contact

Yanqing Li, PhD. MD.

Data sourced from clinicaltrials.gov

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