Investigating Volatile Organic Compounds in Inflammatory Bowel Disease
Non-invasive Disease Activity Monitoring in Patients With Inflammatory Bowel Disease (IBD) Using Volatile Organic Compounds
This study is trying to see if analyzing breath, blood, and stool samples can help diagnose and track the progress of Inflammatory Bowel Disease in patients with Crohn's Disease and Ulcerative Colitis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT04827368 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect clinical data and biological samples, including blood, breath, and stool, from patients diagnosed with Inflammatory Bowel Disease (IBD), specifically Crohn's Disease and Ulcerative Colitis, as well as healthy controls. The goal is to explore the potential of non-invasive methods for diagnosing IBD and understanding its progression over time. By analyzing volatile organic compounds (VOCs) present in the samples, researchers hope to develop better management strategies for IBD patients. Participants will be recruited prior to their scheduled colonoscopy to ensure accurate assessment of disease activity.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-70 diagnosed with Crohn's Disease or Ulcerative Colitis.
Not a fit: Patients who have undergone colectomy or have isolated upper GI Crohn's disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of non-invasive diagnostic tools for IBD, improving patient comfort and outcomes.
How similar studies have performed: While the use of VOCs in diagnosing IBD is a novel approach, similar studies have shown promise in other conditions, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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).
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Florian Rieder, MD — The Cleveland Clinic
- Study coordinator: Samantha Gauriloff
- Email: gaurils@ccf.org
- Phone: 2168946407
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.