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

Overview

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 Title of Study: “Analysis of Volatile Organic Compounds in Exhaled Air in Patients With Inflammatory Bowel Disease Patients and Healthy Control”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 1, 2020

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.

Interventions

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

Arms, Groups and Cohorts

  • 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.
  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Volatile organic compounds differentiating the study groups
    • Time Frame: At the time of breath sampling
    • Volatile organic compounds analysed by GC-MS between the study groups

Secondary Measures

  • Volatile organic compounds differentiating the disease activity
    • Time Frame: At the time of breath sampling
    • Volatile organic compounds analysed by GC-MS between the study groups

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Investigator Details

  • Lead Sponsor
    • Keimyung University Dongsan Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: YooJin Lee, Professor – Keimyung University Dongsan Medical Center
  • Overall Official(s)
    • Yoo Jin Lee, Professor, Principal Investigator, Keimyung University Dongsan Medical Center
  • Overall Contact(s)
    • Yoo Jin Lee, Professor, 82-53-250-8034, doctorlyj@naver.com

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