NCT04827368

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 292 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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, 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.

Conditions

• IBD
• Crohn Disease
• Ulcerative Colitis

Interventions

Type	Name	Description
OTHER	Breath Test	Research Breath sample through disposable mouth filter. Serum sample through routine blood draw. Stool sample through standard collection containers.

Timeline

• Start date: 2021-03-22
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2021-04-01
• Last updated: 2025-07-16

Locations

1 site across 1 country: United States