Volatile Organic Compounds (VOCs) in Active Inflammatory Bowel Disease

Recruiting

• Conditions: IBD; Ulcerative Colitis; Crohn Disease
• Interventions: Other: Breath Test

• Registration Number: NCT04827368
• Lead Sponsor: The Cleveland Clinic

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, 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-22
• Study First Submitted: 2021-03-30
• Study First Submitted QC: 2021-03-30
• Study First Posted: 2021-04-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-23
• Primary Completion: 2024-04-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Crohns Disease	Breath Test	Potential participants will be identified based on their planned/scheduled endoscopy visit.
Ulcerative Colitis	Breath Test	Potential participants will be identified based on their planned/scheduled endoscopy visit.
Non-IBD	Breath Test	Healthy subjects with no bowel disorders will be included as controls.

Primary Outcome Measures

Name	Time	Method
Breath volatile organic compounds (VOC)s and objective markers of Inflammatory Bowel Disease (IBD) Activity	1 year	Correlation of breath VOCs with changes in Fecal Calprotectin.

Secondary Outcome Measures

Name	Time	Method
Breath volatile organic compounds (VOC)s and objective markers of Inflammatory Bowel Disease (IBD) Activity	1 year	Correlation of breath VOCs with changes in C-reactive protein (CRP) and clinical disease activity

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States