NCT04827368Completed
Volatile Organic Compounds (VOCs) in Active Inflammatory Bowel Disease
Non-invasive Disease Activity Monitoring in Patients With Inflammatory Bowel Disease (IBD) Using Volatile Organic Compounds
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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, fatigue and rectal bleeding. However, symptoms and treatment vary between patients. Early management of IBD can lead to better response rates and decrease the risk of irreversible bowel damage and future disease complications such as surgeries. Current clinical tools for diagnosis and or assessing progression of IBD are either invasive (colonoscopy), have low patient acceptance (fecal calprotectin) or low accuracy (C-reactive protein). The purpose of this study is to collect clinical data and samples (including blood, breath and stool) donated by patients with IBD and patients with no IBD (controls) to facilitate research that may result in the development of new non-invasive methods of diagnosing IBD and understand the progression of the disease over time in order to better manage IBD patients.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 292 (actual)
- First submitted
- 30 Mar 2021
- Start date
- 22 Mar 2021
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- The Cleveland Clinic
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT04827368
What you commit to
- Study type: Observational
- Participants enrolled: 292
- From 22 Mar 2021 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects with concurrent chronic liver, renal, lung or metabolic disorders
Other illness
- Active malignancy
- Isolated upper GI Crohn's disease only
- Active disease on colonoscopy, but normal fecal calprotectin at inclusion
Other
- 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)
- Bowel preparation at day of sample procurement
- C diff. positive at time of inclusion (test to be obtained in routine clinical care).
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.