Clinical trial NCT03414580: Analysis of Volatile Organic Compounds in the Exhaled Air in Inflammatory Bowel Disease
Official title: Analysis of Volatile Organic Compounds in Exhaled Air in Patients With Inflammatory Bowel Disease Patients and Healthy Control
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Volatile Organic Compounds
Inflammatory Bowel Disease
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Volatile organic compounds differentiating the study groups
timeFrame: At the time of breath sampling
Secondary outcomes:
measure: Volatile organic compounds differentiating the disease activity
timeFrame: At the time of breath sampling
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: KeimyungUniversity
state: Jung-gu
Study officials:
affiliation: Keimyung University Dongsan Medical Center
name: Yoo Jin Lee, Professor
role: PRINCIPAL_INVESTIGATOR
References: