Confocal Laser Endomicroscopy (CLE) in Patients With Diarrhea

Diarrhea Clinical Trial

Official title:

Confocal Laser Endomicroscopy in Patients With Diarrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072110
• Other study ID #: HN-0001
• Status: Completed
• Start date: February 2010
• Est. completion date: February 2014

Study information

• Verified date: December 2020
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diarrhea

Intervention

Procedure:
• Colonoscopy
Patients will undergo colonoscopy for evaluation of their symptoms.
• Confocal Laser Endomicroscopy
Patients will undergo CLE during their endoscopy. Findings will be compared to group 1.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To investigate whether CLE has a higher sensitivity and specificity than standard colonoscopy in the diagnosis of the cause of diarrhea.		February 2012