NCT01266629

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 24, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

January 11, 2011

Status Verified

October 1, 2010

Enrollment Period

6 months

First QC Date

December 23, 2010

Last Update Submit

January 10, 2011

Conditions

Crohn's Disease

Keywords

small bowel

Outcome Measures

Primary Outcomes (1)

  • correlations between capsule and fecal markers

    To assess the correlations between positive fecal markers and abnormal findings in endoscopic capsule

    end of the study

Secondary Outcomes (1)

  • correlations between serum markers and capsule

    end of the study

Study Arms (1)

capsule patients

All patients that will undergo endoscopic capsule

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek

Jerusalem, Israel

RECRUITING

Related Publications (1)

  • Bar-Gil Shitrit A, Koslowsky B, Livovsky DM, Shitrit D, Paz K, Adar T, Adler SN, Goldin E. A prospective study of fecal calprotectin and lactoferrin as predictors of small bowel Crohn's disease in patients undergoing capsule endoscopy. Scand J Gastroenterol. 2017 Mar;52(3):328-333. doi: 10.1080/00365521.2016.1253769. Epub 2016 Nov 13.

    PMID: 27841040DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Ariella Shitrit, MD

    Shaare Zedek Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariella Shitrit, MD

CONTACT

972-525751515davariel@zahav.net.il

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 23, 2010

First Posted

December 24, 2010

Study Start

December 1, 2010

Primary Completion

June 1, 2011

Study Completion

September 1, 2011

Last Updated

January 11, 2011

Record last verified: 2010-10

Locations

IL(1)