Identifying Saliva Markers in Inflammatory Bowel Disease

Sponsor
Hadassah Medical Organization (Other)
Overall Status
Unknown status
CT.gov ID
NCT01590043
Collaborator
(none)
160
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Salivary samples

Study Design

Study Type:
Observational
Anticipated Enrollment :
160 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Study Start Date :
May 1, 2012
Anticipated Primary Completion Date :
May 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • Salivary Analysis
  • Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      3 Years to 18 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      Site City State Country Postal Code
      1 Hadassah Medical Organization Jerusalem Israel

      Sponsors and Collaborators

      • Hadassah Medical Organization

      Investigators

      • Principal Investigator: Moti Moskovitz, DMD, PhD, Hadassah Medical Organization
      • Principal Investigator: Eyal Shteyer, MD, Hadassah Medical Organization

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      Hadassah Medical Organization
      ClinicalTrials.gov Identifier:
      NCT01590043
      Other Study ID Numbers:
      • LSA002-HMO-CTIL
      First Posted:
      May 2, 2012
      Last Update Posted:
      Sep 7, 2012
      Last Verified:
      Jul 1, 2012
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Sep 7, 2012