Identifying Saliva Markers in Inflammatory Bowel Disease

NCT01590043 | Unknown

• 1 other identifier: LSA002-HMO-CTIL
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Study Arms (3)

Control

Healthy 3-18 years old participants

Other: Salivary samples

Inflammatory bowel disease

3-18 years old patients identified with inflammatory bowel disease

Other: Salivary samples

Abdominal pain

3-18 years old patients suffering from abdominal pain not related to Inflammatory bowel disease

Other: Salivary samples

Interventions

Salivary samples OTHER

Each participant will give a sample of saliva through spitting for 5 minutes in a sterile tube.

Also known as: Salivary Analysis

Abdominal pain; Control; Inflammatory bowel disease

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients identified with infalmmatory bowel disease

You may qualify if:

• Identified with inflammatory bowel disease

You may not qualify if:

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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

RECRUITING

Related Publications (1)

• 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. doi: 10.1002/ibd.20714.

  PMID: 18816678 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole saliva

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Moti Moskovitz, DMD, PhD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

• Eyal Shteyer, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 2, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2013
• Last Updated: September 7, 2012

Record last verified: 2012-07

Locations

IL (1)