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

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

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.

Study Overview

• Status: Unknown
• Conditions: Inflammatory Bowel Disease; Volatile Organic Compounds
• Intervention / Treatment: Procedure: Breath sampling for volatile organic compounds

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 Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

• Study Contact: Name: Yoo Jin Lee, Professor; Phone Number: 82-53-250-8034; Email: doctorlyj@naver.com

Study Locations

• Korea, Republic of
  • Jung-gu
    • Daegu, Jung-gu, Korea, Republic of, 700-712
      • Recruiting
      • KeimyungUniversity
      • Contact: Yoo Jin Lee; Phone Number: +82-250-7088; Email: doctorlyj@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with inflammatory bowel disease visiting the Keimyung University Dong San Medical center will be eligible.

Subject without any gastrointestinal disease or symptom will be eligible as healthy control group.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Breath sampling for volatile organic compounds; Acquisition of exhaled breath sample in exhaled air to 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.	Procedure: Breath sampling for volatile organic compounds; Acquisition of exhaled breath sample in exhaled air to 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.	Procedure: Breath sampling for volatile organic compounds; Acquisition of exhaled breath sample in exhaled air to be analysed by gas chromatography-mass spectrometry

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center
• Investigators: Principal Investigator: Yoo Jin Lee, Professor, Keimyung University Dongsan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2018
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 30, 2018

Study Record Updates

• Last Update Posted (Actual): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: 2017-08-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No