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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01242163
• Other study ID #: 0481-10CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: November 14, 2010
• Last updated: November 22, 2010
• Start date: December 2010
• Est. completion date: December 2012

Study information

• Verified date: October 2010
• Source: Rambam Health Care Campus
• Contact: Amir Karban, MD
• Phone: 972-4-8543401
• Email: a_karban[@]rambam.health.gov.il
• Is FDA regulated: No
• Health authority: health ministry: ISRAEL
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patinets with IBD or IBS

Exclusion Criteria:

• Age under 18 y/o pregnancy, malignant and infectious diseases

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases
• Irritable Bowel Syndrome
• Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus