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

Keimyung University

Status: Unknown

Conditions: Inflammatory Bowel Disease; Volatile Organic Compounds

Treatments: Procedure: Breath sampling for volatile organic compounds

Study type: Observational

Funder types: Other

Identifiers

NCT03414580

2017-08-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

90 participants in 3 patient groups

Ulcerative colitis

Description:

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.

Treatment:

Procedure: Breath sampling for volatile organic compounds

Crohn's disease

Description:

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.

Treatment:

Procedure: Breath sampling for volatile organic compounds

Healthy control

Description:

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

Treatment:

Procedure: Breath sampling for volatile organic compounds