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Identifying Saliva Markers in Inflammatory Bowel Disease

NCT01590043 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2012-09-07

No results posted yet for this study

Summary

Under normal conditions intestinal mucosa presents a baseline "physiological inflammation" caused by a controlled immune response that eliminates offending dietary and microbial antigens. This inflammation disappears once the cause is eradicated. In case of inappropriate immunological response, the inflammation becomes chronic and harmful, resulting in anatomical and functional abnormalities, namely inflammatory bowel disease (IBD).

Although it is critical for the IBD patients to undergo early diagnosis and management before the development of severe complications, but as IBD has vague and non-pathognomonic clinical features, the clinician is usually mislead into late suspicion and detection of IBD.

Diagnosis traditionally depended on a combination of pathologic evaluation together with the histological, clinical, radiological, endoscopic, surgical, laboratory (serological) features. Recently, serological markers were identified and became of special interest as they do not only detect the occurrence of IBD but also the potential of its development and may be used as prognostic tools. More recently, stool markers were detected and used for diagnosis.

Up to now, the market is still lacking a definitive, simple and non-invasive diagnostic tool. Saliva can present an alternative form of body fluids that simplify diagnostic procedures.

Our hypothesis is that IBD patients have special salivary biomarkers that may be identified through salivary analysis, where later on a simple non-invasive test can be applied in the form of an easy-to-use kit, being available at the clinician's clinic for the establishment of an immediate and early diagnosis of the destructive inflammatory bowel disease.

Conditions

  • Inflammatory Bowel Diseases

Interventions

OTHER

Salivary samples

Each participant will give a sample of saliva through spitting for 5 minutes in a sterile tube.

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Moti Moskovitz, DMD, PhD · Hadassah Medical Organization

  • Eyal Shteyer, MD · Hadassah Medical Organization

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-05-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01590043 on ClinicalTrials.gov