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Diarrhea | Confocal Laser Endomicroscopy (CLE) in Patients With Diarrhea

Diarrhea research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Diarrhea

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:ColonoscopyPatients will undergo colonoscopy for evaluation of their symptoms.

Procedure:Confocal Laser EndomicroscopyPatients will undergo CLE during their endoscopy. Findings will be compared to group 1.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Group 1: Patients with diarrhea undergoing endoscopyStandard video colonoscope.

Group 2: Patients with diarrhea undergoing endoscopy.Confocal laser endomicroscopy (CLE).

Study Status

Unknown status

Start Date: February 2010

Completed Date: February 2014

Phase: N/A

Type: Observational

Design:

Primary Outcome: To determine the frequency of different gastrointestinal disorders as the cause of diarrhea in patients at a tertiary referral center using confocal laser endomicroscopy.

Secondary Outcome: To investigate whether CLE has a higher sensitivity and specificity than standard colonoscopy in the diagnosis of the cause of diarrhea.

Study sponsors, principal investigator, and references

Principal Investigator: Markus F. Neurath, M.D., Ph.D.

Lead Sponsor: University of Erlangen-N├╝rnberg Medical School

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01072110

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