Identifying Saliva Markers in Inflammatory Bowel Disease
NCT ID: NCT01590043
Last Updated: 2012-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
160 participants
OBSERVATIONAL
2012-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Control
Healthy 3-18 years old participants
Salivary samples
Each participant will give a sample of saliva through spitting for 5 minutes in a sterile tube.
Inflammatory bowel disease
3-18 years old patients identified with inflammatory bowel disease
Salivary samples
Each participant will give a sample of saliva through spitting for 5 minutes in a sterile tube.
Abdominal pain
3-18 years old patients suffering from abdominal pain not related to Inflammatory bowel disease
Salivary samples
Each participant will give a sample of saliva through spitting for 5 minutes in a sterile tube.
Interventions
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Salivary samples
Each participant will give a sample of saliva through spitting for 5 minutes in a sterile tube.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* congenital syndromes
* children on medication chronically or on the day of the examination
* children treated with radiotherapy or chemotherapy.
3 Years
18 Years
ALL
No
Sponsors
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Hadassah Medical Organization
OTHER
Responsible Party
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Principal Investigators
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Moti Moskovitz, DMD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Organization
Eyal Shteyer, MD
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Organization
Locations
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Hadassah Medical Organization
Jerusalem, , Israel
Countries
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Facility Contacts
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Hadas Lemberg, PhD
Role: primary
References
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Palmon R, Brown SJ, Abreu MT. What is the role and significance of serum and stool biomarkers in the diagnosis of IBD? Inflamm Bowel Dis. 2008 Oct;14 Suppl 2:S187-9. doi: 10.1002/ibd.20714.
Other Identifiers
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LSA002-HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id