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

• Conditions: Inflammatory Bowel Disease; Volatile Organic Compounds
• Interventions: Procedure: Breath sampling for volatile organic compounds

• Registration Number: NCT03414580
• Lead Sponsor: Keimyung University Dongsan Medical Center

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.

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 Timeline

• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-30
• Study Start: 2018-02-20
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-02
• Last Update Posted: 2020-09-03
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

KeimyungUniversity; 🇰🇷 Daegu, Jung-gu, Korea, Republic of