- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01242163
Application of Chemical Sensors for Diagnosis of Inflammatory Bowel Diseases and Irritable Bowel Syndrome by Respiratory Samples
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.
Study Overview
Status
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Amir Karban, MD
- Phone Number: 972-4-8543401
- Email: a_karban@rambam.health.gov.il
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patinets with IBD or IBS
Exclusion Criteria:
- Age under 18 y/o pregnancy, malignant and infectious diseases
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amir Karban, MD, Rambam Medical Center, Haifa, Israel
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0481-10CTIL
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