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

April 30, 2012
September 6, 2012
May 2012
May 2013   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01590043 on ClinicalTrials.gov Archive Site
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Identifying Saliva Markers in Inflammatory Bowel Disease
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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.

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Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Retention:   Samples With DNA
Description:

Whole saliva

Probability Sample

Patients identified with infalmmatory bowel disease

Inflammatory Bowel Diseases
Other: Salivary samples
Each participant will give a sample of saliva through spitting for 5 minutes in a sterile tube.
Other Name: Salivary Analysis
  • Control
    Healthy 3-18 years old participants
    Intervention: Other: Salivary samples
  • Inflammatory bowel disease
    3-18 years old patients identified with inflammatory bowel disease
    Intervention: Other: Salivary samples
  • Abdominal pain
    3-18 years old patients suffering from abdominal pain not related to Inflammatory bowel disease
    Intervention: Other: Salivary samples
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. Erratum in: Inflamm Bowel Dis. 2009 Sep;15(9):1438-47.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
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May 2013   (final data collection date for primary outcome measure)

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.
Both
3 Years to 18 Years
No
Israel
 
NCT01590043
LSA002-HMO-CTIL
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Hadassah Medical Organization
Hadassah Medical Organization
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Principal Investigator: Moti Moskovitz, DMD, PhD Hadassah Medical Organization
Principal Investigator: Eyal Shteyer, MD Hadassah Medical Organization
Hadassah Medical Organization
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP