Identifying Saliva Markers in Inflammatory Bowel Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01590043
First received: April 30, 2012
Last updated: September 6, 2012
Last verified: July 2012
  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

Further study details as provided by Hadassah Medical Organization:

Biospecimen Retention:   Samples With DNA

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
Study Population

Patients identified with infalmmatory bowel disease

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01590043

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: Hadas Lemberg, PhD    0097226777572    lhadas@hadassah.org.il   
Principal Investigator: Moti Moskovich         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
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:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on October 19, 2014