Volatile Organic CompoundsNCT03414580
Analysis of Volatile Organic Compounds in the Exhaled Air in Inflammatory Bowel Disease
An observational study of Volatile Organic Compounds and Inflammatory Bowel Disease, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Volatile Organic Compounds, Inflammatory Bowel Disease
- What is being tested?
- Breath sampling for volatile organic compounds
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Feb 2018to 1 Jun 2021
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- Healthy controls who do not have any gastrointestinal disease or symptom
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
KeimyungUniversity
Daegu, Jung-gu, 700-712
Yoo Jin Lee, +82-250-7088, doctorlyj@naver.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Breath sampling for volatile organic compounds
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath sampling for volatile organic compoundsProcedure or surgery
Acquisition of exhaled breath sample in exhaled air to be analysed by gas chromatography-mass spectrometry
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Breath sampling for volatile organic compounds | |
| 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. Receives: Procedure: Breath sampling for volatile organic compounds | |
| 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. Receives: Procedure: Breath sampling for volatile organic compounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volatile organic compounds differentiating the study groups
Volatile organic compounds analysed by GC-MS between the study groups
Measured: At the time of breath sampling
Secondary outcomes (1)
Volatile organic compounds differentiating the disease activity
Volatile organic compounds analysed by GC-MS between the study groups
Measured: At the time of breath sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start20 Feb 2018
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Volatile Organic CompoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YooJin Lee, Keimyung University Dongsan Medical Center
- Investigators
- Yoo Jin Lee, Professor, Principal investigator, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414580
- Sponsor's protocol ID
- 2017-08-003
- Status last verified
- Sep 2020
- First submitted
- 23 Jan 2018
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Volatile Organic Compounds in Exhaled Air in Patients With Inflammatory Bowel Disease Patients and Healthy Control
- ClinicalTrials.gov ID
- NCT03414580
- Acronym / sponsor ID
- 2017-08-003
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 30 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ulcerative colitis | – | Procedure: Breath sampling for volatile organic compoundsPatients 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 | – | Procedure: Breath sampling for volatile organic compoundsPatients 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 | – | Procedure: Breath sampling for volatile organic compoundsSubject with no intestinal symptoms or no known gastrointestinal disorders. Breath sampling for volatile organic compounds will be analysed by gas chromatography-mass spectrometry. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- Healthy controls who do not have any gastrointestinal disease or symptom
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath sampling for volatile organic compoundsAcquisition of exhaled breath sample in exhaled air to be analysed by gas chromatography-mass spectrometry | Procedure or surgery | Crohn's disease, Healthy control, Ulcerative colitis |
Primary outcome
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
1 secondary outcome
Volatile organic compounds differentiating the disease activity
Time frame: At the time of breath sampling
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoo Jin Lee, Professor principal investigator
Keimyung University Dongsan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Volatile Organic Compounds and Inflammatory Bowel Disease, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoo Jin Lee, Professor (82-53-250-8034, doctorlyj@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volatile organic compounds differentiating the study groups (time frame: At the time of breath sampling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.