Confocal Laser Endomicroscopy (CLE) in Patients With Diarrhea
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|ClinicalTrials.gov Identifier: NCT01072110|
Recruitment Status : Unknown
Verified January 2013 by Helmut Neumann, University of Erlangen-Nürnberg Medical School.
Recruitment status was: Recruiting
First Posted : February 19, 2010
Last Update Posted : January 24, 2013
|Condition or disease||Intervention/treatment|
|Diarrhea||Procedure: Colonoscopy Procedure: Confocal Laser Endomicroscopy|
Diarrhea is characterized by frequent, loose, and watery bowel movements. Common causes include various gastrointestinal infections (e.g. clostridium difficile, salmonella), inflammatory bowel disease (ulcerative colitis, Crohn´s disease), drugs (e.g. antibiotics) and malabsorption syndromes (e.g. celiac and Whipple's disease). Confocal laser endomicroscopy (CLE) is rapidly emerging as a valuable tool for gastrointestinal endoscopic imaging, enabling the endoscopist to obtain an "optical biopsy" of the gastrointestinal mucosa during the endoscopic procedure.
In patients with diarrhea.
Patients were randomized in two groups. Group 1: Patients underwent standard video colonoscopy for the evaluation of their symptoms. Group 2: During the endoscopic procedure CLE will be performed additionally.
The patient underwent colonoscopy. In Group 2 patients´ will receive intravenous fluorescein or topical mucosal staining with acriflavin or cresyl violet during the procedure, followed by in-vivo CLE of the tissue. Confocal images are digitally saved and analyzed afterwards.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Confocal Laser Endomicroscopy in Patients With Diarrhea|
|Study Start Date :||February 2010|
|Estimated Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||February 2014|
Group 1: Patients with diarrhea undergoing endoscopy
Standard video colonoscope.
Patients will undergo colonoscopy for evaluation of their symptoms.
Group 2: Patients with diarrhea undergoing endoscopy.
Confocal laser endomicroscopy (CLE).
Procedure: Confocal Laser Endomicroscopy
Patients will undergo CLE during their endoscopy. Findings will be compared to group 1.
- To determine the frequency of different gastrointestinal disorders as the cause of diarrhea in patients at a tertiary referral center using confocal laser endomicroscopy. [ Time Frame: February 2012 ]
- To investigate whether CLE has a higher sensitivity and specificity than standard colonoscopy in the diagnosis of the cause of diarrhea. [ Time Frame: February 2012 ]
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): NCT01072110
|Contact: Markus F Neurath, M.D, Ph.D.||email@example.com|
|Contact: Helmut Neumann, M.D., Ph.D.||firstname.lastname@example.org|
|Erlangen, Germany, 91054|
|Contact: Markus F. Neurath, M.D., Ph.D.|
|Sub-Investigator: Helmut Neumann, M.D., Ph.D.|
|Principal Investigator:||Markus F. Neurath, M.D., Ph.D.||Department of Medicine I, University of Erlangen-Nuremberg|