NCT03414580

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

February 20, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

3.3 years

First QC Date

January 23, 2018

Last Update Submit

September 2, 2020

Conditions

Volatile Organic CompoundsInflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Volatile organic compounds differentiating the disease activity

    At the time of breath sampling

Study Arms (3)

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

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

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

Interventions

Breath sampling for volatile organic compoundsPROCEDURE

Acquisition of exhaled breath sample in exhaled air to be analysed by gas chromatography-mass spectrometry

Crohn's diseaseHealthy controlUlcerative colitis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis)
  • Healthy controls who do not have any gastrointestinal disease or symptom

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KeimyungUniversity

Daegu, Jung-gu, 700-712, South Korea

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Volatile Organic Compounds

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Organic Chemicals

Study Officials

  • Yoo Jin Lee, Professor

    Keimyung University Dongsan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoo Jin Lee, Professor

CONTACT

82-53-250-8034doctorlyj@naver.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 23, 2018

First Posted

January 30, 2018

Study Start

February 20, 2018

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

September 3, 2020

Record last verified: 2020-09

Locations

KR(1)