Volatile Organic Compounds (VOCs) in Active Inflammatory Bowel Disease (VOC)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Crohn Disease; Ulcerative Colitis; IBD
• Intervention / Treatment: Other: Breath Test

• Study Type: Observational
• Enrollment (Actual): 292

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This is a prospective, controlled, non-interventional cohort study, conducted at the Cleveland Clinic IBD Center, using serially obtained breath and serum headspace VOCs as non-invasive biomarkers to detect disease activity in IBD, fecal calprotectin, CRP, and patient-reported outcome tools. No drug will be evaluated in this study. All visits for this study as well as the initial endoscopy will be based on standard clinical practice and guidelines.

At inclusion, all patients will have a colonoscopy (indication is standard of care), CRP, fecal calprotectin, and baseline PRO2 to establish the pattern for disease activity, which will subsequently be evaluated for change by using fecal calprotectin, CRP, and PRO2 over one year (every 3 months), as a surrogate marker for disease activity.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Crohns Disease; Potential participants will be identified based on their planned/scheduled endoscopy visit.	Other: Breath Test; Research Breath sample through disposable mouth filter. Serum sample through routine blood draw. Stool sample through standard collection containers.; Other Names: Serum Samples; Stool Samples
Ulcerative Colitis; Potential participants will be identified based on their planned/scheduled endoscopy visit.	Other: Breath Test; Research Breath sample through disposable mouth filter. Serum sample through routine blood draw. Stool sample through standard collection containers.; Other Names: Serum Samples; Stool Samples
Non-IBD; Healthy subjects with no bowel disorders will be included as controls.	Other: Breath Test; Research Breath sample through disposable mouth filter. Serum sample through routine blood draw. Stool sample through standard collection containers.; Other Names: Serum Samples; Stool Samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: AbbVie
• Investigators: Principal Investigator: Florian Rieder, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: IBD, VOC
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Crohn Disease; Inflammatory Bowel Diseases
• Other Study ID Numbers: 20-1149; B19-566 (Other Identifier: Abbvie)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No