NCT01242163

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2010

Completed
15 days until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 23, 2010

Status Verified

October 1, 2010

First QC Date

November 14, 2010

Last Update Submit

November 22, 2010

Conditions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Inflammtory bowel Diseases and IBS

You may qualify if:

  • Patinets with IBD or IBS

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Experiated lung air

MeSH Terms

Conditions

Inflammatory Bowel DiseasesIrritable Bowel Syndrome

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColonic Diseases, FunctionalColonic Diseases

Study Officials

  • Amir Karban, MD

    Rambam Medical Center, Haifa, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 14, 2010

First Posted

November 16, 2010

Study Start

December 1, 2010

Study Completion

December 1, 2012

Last Updated

November 23, 2010

Record last verified: 2010-10