Status:
ACTIVE_NOT_RECRUITING
Volatile Organic Compounds (VOCs) in Active Inflammatory Bowel Disease
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
AbbVie
Conditions:
IBD
Crohn Disease
Eligibility:
All Genders
18-70 years
Brief Summary
Inflammatory Bowel Disease (IBD) are chronic diseases of the gut comprising Crohn's Disease (CD) and Ulcerative Colitis (UC). The symptoms of IBD consist of diarrhea, abdominal discomfort, weight loss...
Eligibility Criteria
Inclusion
- Diagnosed as having Crohn's Disease or Ulcerative Colitis
- Aged 18-70 years.
- Understands the language and signs an informed consent form.
- Any disease location, except isolated upper GI Crohn's disease only
- Any CD or UC disease activity.
- Outpatients and inpatients
- Patients will be recruited, and samples obtained at least one day, and no more than one week, prior to out/inpatient colonoscopy preparation to allow objective assessment of disease activity.
Exclusion
- Status post colectomy
- Status post diverting loop ileostomy or end ileostomy or colostomy
- On antibiotics in the past 3 months or currently
- Women (pregnant or breast feeding)
- Subjects with concurrent chronic liver, renal, lung or metabolic disorders
- Active malignancy
- Bowel preparation at day of sample procurement
- Isolated upper GI Crohn's disease only
- Active disease on colonoscopy, but normal fecal calprotectin at inclusion
- C diff. positive at time of inclusion (test to be obtained in routine clinical care).
Key Trial Info
Start Date :
March 22 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
292 Patients enrolled
Trial Details
Trial ID
NCT04827368
Start Date
March 22 2021
End Date
June 30 2026
Last Update
July 16 2025
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195