Volatile Organic Compounds (VOCs) in Active Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

— VOC  

Official title:

Non-invasive Disease Activity Monitoring in Patients With Inflammatory Bowel Disease (IBD) Using Volatile Organic Compounds

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04827368
• Other study ID #: 20-1149
• Secondary ID: B19-566
• Status: Recruiting
• Start date: March 22, 2021
• Est. completion date: September 30, 2025

Study information

• Verified date: October 2023
• Source: The Cleveland Clinic
• Contact: Ronald Ottichilo
• Phone: 2163727109
• Email: ottichr[@]ccf.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 30, 2025
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Crohn Disease
• IBD
• Inflammatory Bowel Diseases
• Ulcerative Colitis

Intervention

Other:
• Breath Test
Research Breath Test

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Breath volatile organic compounds (VOC)s and objective markers of Inflammatory Bowel Disease (IBD) Activity	Correlation of breath VOCs with endoscopic disease activity	1 year
Primary	Breath volatile organic compounds (VOC)s and objective markers of Inflammatory Bowel Disease (IBD) Activity	Correlation of breath VOCs with changes in Fecal Calprotectin.	1 year
Secondary	Breath volatile organic compounds (VOC)s and objective markers of Inflammatory Bowel Disease (IBD) Activity	Correlation of breath VOCs with changes in C-reactive protein (CRP) and clinical disease activity	1 year