Identifying Saliva Markers in Inflammatory Bowel Disease

• Conditions: Inflammatory Bowel Diseases
• Interventions: Other: Salivary samples

• Registration Number: NCT01590043
• Lead Sponsor: Hadassah Medical Organization

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-30
• Study First Submitted QC: 2012-04-30
• Study Start: 2012-05
• Study First Posted: 2012-05-02
• Status Verified: 2012-07
• Last Update Submitted: 2012-09-06
• Last Update Posted: 2012-09-07
• Primary Completion: 2013-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Identified with inflammatory bowel disease

Exclusion Criteria

• medically compromised children
• congenital syndromes
• children on medication chronically or on the day of the examination
• children treated with radiotherapy or chemotherapy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Salivary samples	Healthy 3-18 years old participants
Abdominal pain	Salivary samples	3-18 years old patients suffering from abdominal pain not related to Inflammatory bowel disease
Inflammatory bowel disease	Salivary samples	3-18 years old patients identified with inflammatory bowel disease

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel