Identifying Saliva Markers in Inflammatory Bowel Disease
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Inflammatory Bowel Diseases |
Other: Salivary samples |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
Whole saliva
| Estimated Enrollment: | 160 |
| Study Start Date: | May 2012 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Control
Healthy 3-18 years old participants
|
Other: Salivary samples
Each participant will give a sample of saliva through spitting for 5 minutes in a sterile tube.
Other Name: Salivary Analysis
|
|
Inflammatory bowel disease
3-18 years old patients identified with inflammatory bowel disease
|
Other: Salivary samples
Each participant will give a sample of saliva through spitting for 5 minutes in a sterile tube.
Other Name: Salivary Analysis
|
|
Abdominal pain
3-18 years old patients suffering from abdominal pain not related to Inflammatory bowel disease
|
Other: Salivary samples
Each participant will give a sample of saliva through spitting for 5 minutes in a sterile tube.
Other Name: Salivary Analysis
|
Eligibility| Ages Eligible for Study: | 3 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients identified with infalmmatory bowel disease
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.
Contacts and Locations| Israel | |
| Hadassah Medical Organization | Recruiting |
| Jerusalem, Israel | |
| Contact: Hadas Lemberg, PhD 0097226777572 lhadas@hadassah.org.il | |
| Principal Investigator: Moti Moskovich | |
| Principal Investigator: | Moti Moskovitz, DMD, PhD | Hadassah Medical Organization |
| Principal Investigator: | Eyal Shteyer, MD | Hadassah Medical Organization |
More Information
Publications:
| Responsible Party: | Hadassah Medical Organization |
| ClinicalTrials.gov Identifier: | NCT01590043 History of Changes |
| Other Study ID Numbers: | LSA002-HMO-CTIL |
| Study First Received: | April 30, 2012 |
| Last Updated: | September 6, 2012 |
| Health Authority: | Israel: Ministry of Health |
Additional relevant MeSH terms:
|
Inflammatory Bowel Diseases Intestinal Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013