Diarrhea
Conditions
Keywords
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.
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.
Interventions
PROCEDUREColonoscopy
Patients will undergo colonoscopy for evaluation of their symptoms.
PROCEDUREConfocal Laser Endomicroscopy
Patients will undergo CLE during their endoscopy. Findings will be compared to group 1.
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Age 18-85 years * Ability of subjects to understand character and individual consequences of clinical trial * Subjects undergoing colonoscopy
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To investigate whether CLE has a higher sensitivity and specificity than standard colonoscopy in the diagnosis of the cause of diarrhea. | February 2012 |
Countries
Germany
Outcome results
None listed