Confocal Laser Endomicroscopy (CLE) in Patients With Diarrhea
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 17, 2010
CompletedFirst Posted
Study publicly available on registry
February 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedDecember 14, 2020
December 1, 2020
3.9 years
February 17, 2010
December 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
February 2012
Secondary Outcomes (1)
To investigate whether CLE has a higher sensitivity and specificity than standard colonoscopy in the diagnosis of the cause of diarrhea.
February 2012
Study Arms (2)
Group 1: Patients with diarrhea undergoing endoscopy
Standard video colonoscope.
Group 2: Patients with diarrhea undergoing endoscopy.
Confocal laser endomicroscopy (CLE).
Interventions
Patients will undergo colonoscopy for evaluation of their symptoms.
Patients will undergo CLE during their endoscopy. Findings will be compared to group 1.
Eligibility Criteria
Patients of a tertiary referral hospital.
You may qualify if:
- Written informed consent
- Age 18-85 years
- Ability of subjects to understand character and individual consequences of clinical trial
- Subjects undergoing colonoscopy
You may not qualify if:
- Inability to provide written informed consent
- Severe Coagulopathy (Prothrombin time \< 50% of control, Partial thromboplastin time \> 50 s)
- Impaired renal function (Creatinine \> 1.2 mg/dl)
- Pregnancy or breast feeding
- Active gastrointestinal bleeding
- Known allergy to fluorescein, acriflavin or cresyl violet
- Residing in institutions (e.g. prison)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Erlangen, 91054, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Markus F. Neurath, M.D., Ph.D.
Department of Medicine I, University of Erlangen-Nuremberg
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2010
First Posted
February 19, 2010
Study Start
February 1, 2010
Primary Completion
January 1, 2014
Study Completion
February 1, 2014
Last Updated
December 14, 2020
Record last verified: 2020-12