Analysis of Volatile Organic Compounds in the Exhaled Air in Inflammatory Bowel Disease

Sponsor

Keimyung University Dongsan Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03414580

Collaborator

(none)

Enrollment

Location

39.3

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The availability of noninvasive biomarkers for diagnosis and stratification of inflammatory bowel disease (IBD) courses is lacking. Thus, the aim of this study is to evaluated the accuracy of exhaled breath volatile metabolite analysis on diagnosis and stratification of patients with inflammatory bowel disease.

Condition or Disease	Intervention/Treatment	Phase
Volatile Organic Compounds Inflammatory Bowel Disease	Procedure: Breath sampling for volatile organic compounds

Detailed Description

Background: The diagnosis and differentiation of inflammatory bowel diseases (IBD) is challenging due to the absence of a gold standard diagnostic modality for confirmation. Exhaled breath volatile metabolite analysis focusing on diagnosis and differentiation of IBD is a promising approach. Thus, the aim of this study is to evaluated the accuracy of exhaled breath volatile metabolite analysis for patients with inflammatory bowel disease.

Method: A single center, prospective study of diagnostic testing will be conducted, recruiting crohn's disease (CD), ulcerative colitis (UC), and healthy controls (HC). The exhaled breath volatile metabolite will be analyzed using gas chromatography/mass spectrometry (GC-MS). The informations of patient's disease location, disease activity, laboratory parameters and current medications will be collected to determine the feasibility of exhaled breath volatile metabolite analysis.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Analysis of Volatile Organic Compounds in Exhaled Air in Patients With Inflammatory Bowel Disease Patients and Healthy Control

Actual Study Start Date :

Feb 20, 2018

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Ulcerative colitis Patients with ulcerative colitis whose diagnosis had established on clinical, endoscopic, histologic, and/or radiological criteria. Breath sampling for volatile organic compounds will be analysed by gas chromatography-mass spectrometry.	Procedure: Breath sampling for volatile organic compounds Acquisition of exhaled breath sample in exhaled air to be analysed by gas chromatography-mass spectrometry
Crohn's disease Patients with crohn's disease whose diagnosis had established on clinical, endoscopic, histologic, and/or radiological criteria. Breath sampling for volatile organic compounds will be analysed by gas chromatography-mass spectrometry.	Procedure: Breath sampling for volatile organic compounds Acquisition of exhaled breath sample in exhaled air to be analysed by gas chromatography-mass spectrometry
Healthy control Subject with no intestinal symptoms or no known gastrointestinal disorders. Breath sampling for volatile organic compounds will be analysed by gas chromatography-mass spectrometry.	Procedure: Breath sampling for volatile organic compounds Acquisition of exhaled breath sample in exhaled air to be analysed by gas chromatography-mass spectrometry

Arm

Intervention/Treatment

Ulcerative colitis

Patients with ulcerative colitis whose diagnosis had established on clinical, endoscopic, histologic, and/or radiological criteria. Breath sampling for volatile organic compounds will be analysed by gas chromatography-mass spectrometry.

Procedure: Breath sampling for volatile organic compounds

Acquisition of exhaled breath sample in exhaled air to be analysed by gas chromatography-mass spectrometry

Crohn's disease

Patients with crohn's disease whose diagnosis had established on clinical, endoscopic, histologic, and/or radiological criteria. Breath sampling for volatile organic compounds will be analysed by gas chromatography-mass spectrometry.

Procedure: Breath sampling for volatile organic compounds

Acquisition of exhaled breath sample in exhaled air to be analysed by gas chromatography-mass spectrometry

Healthy control

Subject with no intestinal symptoms or no known gastrointestinal disorders. Breath sampling for volatile organic compounds will be analysed by gas chromatography-mass spectrometry.

Procedure: Breath sampling for volatile organic compounds

Acquisition of exhaled breath sample in exhaled air to be analysed by gas chromatography-mass spectrometry

Outcome Measures

Primary Outcome Measures

Volatile organic compounds differentiating the study groups [At the time of breath sampling]
Volatile organic compounds analysed by GC-MS between the study groups

Secondary Outcome Measures

Volatile organic compounds differentiating the disease activity [At the time of breath sampling]
Volatile organic compounds analysed by GC-MS between the study groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis)
Healthy controls who do not have any gastrointestinal disease or symptom

Exclusion Criteria:

Pregnant or lactating woman
Subjects who diagnosed liver cirrhosis, severe congestive heart failure, severe renal insufficiency, uncontrolled hypertension, endocrine disorder, metabolic disorder, prior malignancy, immune deficiency
Subjects with mental retardation and cognitive impairment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KeimyungUniversity	Daegu	Jung-gu	Korea, Republic of	700-712

Sponsors and Collaborators

Keimyung University Dongsan Medical Center

Investigators

Principal Investigator: Yoo Jin Lee, Professor, Keimyung University Dongsan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

YooJin Lee, Professor, Keimyung University Dongsan Medical Center

ClinicalTrials.gov Identifier:

NCT03414580

Other Study ID Numbers:

2017-08-003

First Posted:

Jan 30, 2018

Last Update Posted:

Sep 3, 2020

Last Verified:

Sep 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Intestinal Diseases

Inflammatory Bowel Diseases

Study Results

No Results Posted as of Sep 3, 2020