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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
Information provided by:
Shaare Zedek Medical Center Identifier:
First received: December 23, 2010
Last updated: January 10, 2011
Last verified: October 2010
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.

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)
capsule patients
All patients that will undergo endoscopic capsule

  Show Detailed Description


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.

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
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 identifier: NCT01266629

Contact: Ariella Shitrit, MD 972-525751515

Shaare Zedek Recruiting
Jerusalem, Israel
Contact: Ariella Shitrit, MD    972-26555111   
Sponsors and Collaborators
Shaare Zedek Medical Center
Principal Investigator: Ariella Shitrit, MD Shaare Zedek Medical Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ariella Shitrit Shaare Zedek Medical Center, Shaare Zedek Medical Center Identifier: NCT01266629     History of Changes
Other Study ID Numbers: 2010-147
Study First Received: December 23, 2010
Last Updated: January 10, 2011

Keywords provided by Shaare Zedek Medical Center:
small bowel

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Anti-Infective Agents processed this record on August 18, 2017