Confocal Laser Endomicroscopy (CLE) in Patients With Diarrhea
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| First Received Date ICMJE | February 17, 2010 | ||||||||
| Last Updated Date | January 23, 2013 | ||||||||
| Start Date ICMJE | February 2010 | ||||||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01072110 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Confocal Laser Endomicroscopy (CLE) in Patients With Diarrhea | ||||||||
| Official Title ICMJE | Confocal Laser Endomicroscopy in Patients With Diarrhea | ||||||||
| Brief Summary | The main objective of this study is to determine the frequency of different gastrointestinal disorders as the cause of diarrhea in patients at a tertiary referral center using confocal laser endomicroscopy. |
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| Detailed Description | Background: 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. Scope: In patients with diarrhea. Methods: 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. Procedure: 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Time Perspective: Prospective | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients of a tertiary referral hospital. |
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| Condition ICMJE | Diarrhea | ||||||||
| Intervention ICMJE |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Estimated Completion Date | February 2014 | ||||||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 85 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01072110 | ||||||||
| Other Study ID Numbers ICMJE | HN-0001 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Helmut Neumann, University of Erlangen-Nürnberg Medical School | ||||||||
| Study Sponsor ICMJE | University of Erlangen-Nürnberg Medical School | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Erlangen-Nürnberg Medical School | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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