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The Clinical Utility of Fecal Caprotectin and Lactoferrin in Patients Undergoing Capsular Endoscopy

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 October 2010 by Shaare Zedek Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01266629
First Posted: December 24, 2010
Last Update Posted: January 11, 2011
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:
Shaare Zedek Medical Center
  Purpose
Capsule endoscopy (CE) is considered as a gold standard examination for small bowel Crohn's disease. However, it is time-consuming, expensive and results are largely influenced by the operator's skills. We, therefore, want to assess the predictive value of fecal calprotectin and lactoferrin in patients undergoing CE.

Condition
Crohn's Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Clinical Utility of Fecal Calprotectin and Lactoferrin in Patients Undergoing Capsular Endoscopy: A Prospective Study

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • correlations between capsule and fecal markers [ Time Frame: end of the study ]
    To assess the correlations between positive fecal markers and abnormal findings in endoscopic capsule


Secondary Outcome Measures:
  • correlations between serum markers and capsule [ Time Frame: end of the study ]
    correlations between CRP, ESR , PLT and abnormal findings in capsule


Estimated Enrollment: 40
Study Start Date: December 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
capsule patients
All patients that will undergo endoscopic capsule

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
consecutive patients referred for capsule on an outpatient basis will include in the study. Indications for EC will be suspicion of crohn's disease, unexplained anemia, and bleeding, and abnormal findings in commuted tomography. All patients underwent non diagnostic colonoscopy and gastroscopy prior to EC referral.
Criteria

Inclusion Criteria:All consecutive patients referred for endoscopic capsule -

Exclusion Criteria:Intake of nonsteroidal agents and/or antibiotics during the three months preceding the study, concomitant serious illness, pregnancy, alcohol abuse, and evidence of a respiratory tract infection.

  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): NCT01266629


Contacts
Contact: Ariella Shitrit, MD 972-525751515 davariel@zahav.net.il

Locations
Israel
Shaare Zedek Recruiting
Jerusalem, Israel
Contact: Ariella Shitrit, MD    972-26555111    davariel@zahav.net.il   
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Ariella Shitrit, MD Shaare Zedek Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ariella Shitrit Shaare Zedek Medical Center, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT01266629     History of Changes
Other Study ID Numbers: 2010-147
First Submitted: December 23, 2010
First Posted: December 24, 2010
Last Update Posted: January 11, 2011
Last Verified: October 2010

Keywords provided by Shaare Zedek Medical Center:
small bowel

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Lactoferrin
Anti-Infective Agents