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

Inflammatory Bowel Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03414580
• Other study ID #: 2017-08-003
• Status: Recruiting
• Start date: February 20, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: September 2020
• Source: Keimyung University Dongsan Medical Center
• Contact: Yoo Jin Lee, Professor
• Phone: 82-53-250-8034
• Email: doctorlyj[@]naver.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Volatile Organic Compounds

Intervention

Procedure:
• Breath sampling for volatile organic compounds
Acquisition of exhaled breath sample in exhaled air to be analysed by gas chromatography-mass spectrometry

Locations

Country	Name	City	State
Korea, Republic of	KeimyungUniversity	Daegu	Jung-gu

Sponsors (1)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volatile organic compounds differentiating the study groups	Volatile organic compounds analysed by GC-MS between the study groups	At the time of breath sampling
Secondary	Volatile organic compounds differentiating the disease activity	Volatile organic compounds analysed by GC-MS between the study groups	At the time of breath sampling