Application of Chemical Sensors for Diagnosis of Inflammatory Bowel Diseases and Irritable Bowel Syndrome by Respiratory Samples

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Rambam Health Care Campus.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01242163
First received: November 14, 2010
Last updated: November 22, 2010
Last verified: October 2010
  Purpose

Discriminating irritable bowel syndrome (IBS) from inflammatory bowel disease (IBD), especially with mild disease activity, is common clinical challenge. Most of the patients with suspected IBS have to go invasive procedures (colonoscopy/gastroscopy). In order to avoid invasive investigations, there is a search for noninvasive markers with the capacity to distinguish between IBS and IBD. Dr Hossam Haick (Department of Chemical Engineering, Technion) developed a system that combines nano-metals produced in his laboratory with electrical devices (transistors). The combination between a nanomaterial and an electrical transistor induces a change in its electrical behavior upon exposure to the material being examined; that is, a change in its electrical properties. The change in its electrical behavior is translated into a computerized graphic signal.

The electronic nose is composed of an air pump, a filter for filtering external contaminants and an array of sensors. Each sensor transmits a signal according to the materials it "knows" how to identify. Thus, it is possible to characterize most of the substance families characteristic of a certain disease, and the same system is designed for differential diagnosis of different diseases.

The purpose of the investigators study is to use the "electronic nose" to find bio-markers that will help to diagnose IBD and IBS without using invasive procedures.

The plan is to collect 200 samples (50 IBS' 50 Crohn's disease, 50 ulcerative colitis and 50 controls). The patients included in the study will undergo an evaluation by a gastroenterologist after signing an informed consent and will answer a questionnaire.

The samples will analyzed in the laboratory of Dr. Haick.


Condition
Inflammatory Bowel Diseases
Irritable Bowel Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Application of Chemical Sensors for Diagnosis of Inflammatory Bowel Diseases and Irritable Bowel Syndrome by Respiratory Samples

Further study details as provided by Rambam Health Care Campus:

Biospecimen Retention:   Samples Without DNA

Experiated lung air


Estimated Enrollment: 200
Study Start Date: December 2010
Estimated Study Completion Date: December 2012
Detailed Description:

The plan is to collect 200 samples (50 IBS' 50 Crohn's disease, 50 ulcerative colitis and 50 controls). The patients included in the study will undergo an evaluation by a gastroenterologist after signing an informed consent and will answer a questionnaire.

The samples will analyzed in the laboratory of Dr. Haick.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients with Inflammtory bowel Diseases and IBS

Criteria

Inclusion Criteria:

  • Patinets with IBD or IBS

Exclusion Criteria:

  • Age under 18 y/o pregnancy, malignant and infectious diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242163

Contacts
Contact: Amir Karban, MD 972-4-8543401 a_karban@rambam.health.gov.il

Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Amir Karban, MD Rambam Medical Center, Haifa, Israel
  More Information

No publications provided

Responsible Party: Dr Amir Karban, Rambam Medical Center
ClinicalTrials.gov Identifier: NCT01242163     History of Changes
Other Study ID Numbers: 0481-10CTIL
Study First Received: November 14, 2010
Last Updated: November 22, 2010
Health Authority: health ministry: ISRAEL

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on September 30, 2014