Volatile Organic Compounds (VOCs) of Exhaled Breath in Patients With GI Bleeding

Gastrointestinal Hemorrhage Clinical Trial

Official title:

Analysis of Volatile Organic Compound (VOC) in Exhaled Breath for the Detection of Gastrointestinal Bleeding

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04226079
• Other study ID #: 1911-086-107
• Status: Recruiting
• Start date: January 2020
• Est. completion date: July 2020

Study information

• Verified date: January 2020
• Source: Seoul National University Hospital
• Contact: JIN JU CHOI, M.D.
• Phone: 01028087284
• Email: wallet87[@]hanmail.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Cross sectional case-control study investigating the difference of volatile organic compound in the exhaled breath of the patients with GI bleeding and normal population.

Description:

This study investigates the difference of volatile organic compound in the exhaled breath of the patients with GI bleeding and normal population. We aimed to find out the biomarkers for GI bleeding.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adults aged between 20 and 80

• Low possibility of gastrointestinal bleeding was proven by esophagogastroduodenoscopy and colonoscopy which were performed within 1 year.

• NSAID non-user (within 1 months before the date of inclusion)

Exclusion Criteria:

• Diagnosis of malignancy diagnosed within 5 years

• Past medical history of chronic liver disease, chronic kidney disease, chronic lung disease, chronic bronchial disease, asthma

• Surgical history of any kind of gastrectomy

• Surgical history of any kind of lung resection which could impact the patient's lung function.

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Volatile Organic Compounds

Intervention

Diagnostic Test:
• Collection of exhaled breath
Collection of exhaled breath will be analyzed for specific volatile organic compounds which show different distribution between groups

Locations

Country	Name	City	State
Korea, Republic of	Jin Ju Choi	Seoul	Gyunggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VOC Patterns	Patterns of volatile organic compounds recognized by sensor array	1 day of 1st emergency room (ER) visit for GI bleeding
Secondary	Measurement of VOC	Qualitative and quantitative assay of volatile organic compounds by GC-MS	1 day of 1st emergency room (ER) visit for GI bleeding
Secondary	Change of VOC patterns	Change of the patterns of volatile organic compounds recognized by sensor array after recovery from GI bleeding	2nd visit (about 2weeks apart from 1st visit)