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Confocal Laser Endomicroscopy (CLE) in Patients With Diarrhea

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Helmut Neumann, University of Erlangen-Nürnberg Medical School.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01072110
First Posted: February 19, 2010
Last Update Posted: January 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Helmut Neumann, University of Erlangen-Nürnberg Medical School
  Purpose
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.

Condition Intervention
Diarrhea Procedure: Colonoscopy Procedure: Confocal Laser Endomicroscopy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Confocal Laser Endomicroscopy in Patients With Diarrhea

Resource links provided by NLM:


Further study details as provided by Helmut Neumann, University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: February 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1: Patients with diarrhea undergoing endoscopy
Standard video colonoscope.
Procedure: Colonoscopy
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of a tertiary referral hospital.
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Markus F Neurath, M.D, Ph.D. markus.neurath@uk-erlangen.de
Contact: Helmut Neumann, M.D., Ph.D. helmut.neumann@uk-erlangen.de

Locations
Germany
Recruiting
Erlangen, Germany, 91054
Contact: Markus F. Neurath, M.D., Ph.D.         
Sub-Investigator: Helmut Neumann, M.D., Ph.D.         
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Principal Investigator: Markus F. Neurath, M.D., Ph.D. Department of Medicine I, University of Erlangen-Nuremberg
  More Information

Responsible Party: Helmut Neumann, Professor, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01072110     History of Changes
Other Study ID Numbers: HN-0001
First Submitted: February 17, 2010
First Posted: February 19, 2010
Last Update Posted: January 24, 2013
Last Verified: January 2013

Keywords provided by Helmut Neumann, University of Erlangen-Nürnberg Medical School:
Patients with diarrhea

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms