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Identifying Saliva Markers in Inflammatory Bowel Disease

H

Hadassah Medical Center

Status

Unknown

Conditions

Inflammatory Bowel Diseases

Treatments

Other: Salivary samples

Study type

Observational

Funder types

Other

Identifiers

NCT01590043
LSA002-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment

160 estimated patients

Sex

All

Ages

3 to 18 years old

Volunteers

No Healthy Volunteers

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.

Trial design

160 participants in 3 patient groups

Control
Description:
Healthy 3-18 years old participants
Treatment:
Other: Salivary samples
Inflammatory bowel disease
Description:
3-18 years old patients identified with inflammatory bowel disease
Treatment:
Other: Salivary samples
Abdominal pain
Description:
3-18 years old patients suffering from abdominal pain not related to Inflammatory bowel disease
Treatment:
Other: Salivary samples

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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