Trial record 13 of 1157 for:    diarrhea

Confocal Laser Endomicroscopy (CLE) in Patients With Diarrhea

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Erlangen-Nürnberg Medical School
Sponsor:
Information provided by (Responsible Party):
Helmut Neumann, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01072110
First received: February 17, 2010
Last updated: January 23, 2013
Last verified: January 2013
  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 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Helmut Neumann, Professor, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01072110     History of Changes
Other Study ID Numbers: HN-0001
Study First Received: February 17, 2010
Last Updated: January 23, 2013
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on July 23, 2014