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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Volatile Organic Compounds, Inflammatory Bowel Disease

Intervention / Treatment
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* Procedure: Breath sampling for volatile organic compounds


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ulcerative colitis<br>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<br>* Acquisition of exhaled breath sample in exhaled air to be analysed by gas chromatography-mass spectrometry<br>|
| Crohn's disease<br>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<br>* Acquisition of exhaled breath sample in exhaled air to be analysed by gas chromatography-mass spectrometry<br>|
| Healthy control<br>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<br>* Acquisition of exhaled breath sample in exhaled air to be analysed by gas chromatography-mass spectrometry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volatile organic compounds differentiating the disease activity | Volatile organic compounds analysed by GC-MS between the study groups | At the time of breath sampling |