Volatile Organic Compounds (VOCs) in Active Inflammatory Bowel Disease

NCT04827368 | Active Not Recruiting

• 2 other identifiers: 20-1149B19-566
• Study Type: observational
• Target: 292
• Locations: 1 country
• Sites: 1

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.

Conditions

IBD; Crohn Disease; Ulcerative Colitis

Keywords

IBD, VOC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Breath volatile organic compounds (VOC)s and objective markers of Inflammatory Bowel Disease (IBD) Activity

  1 year

Other Outcomes (1)

• Breath volatile organic compounds (VOC)s and objective markers of Inflammatory Bowel Disease (IBD) Activity

  1 year

Study Arms (3)

Crohns Disease

Potential participants will be identified based on their planned/scheduled endoscopy visit.

Other: Breath Test

Ulcerative Colitis

Potential participants will be identified based on their planned/scheduled endoscopy visit.

Other: Breath Test

Non-IBD

Healthy subjects with no bowel disorders will be included as controls.

Other: Breath Test

Interventions

Breath Test OTHER

Research Breath sample through disposable mouth filter. Serum sample through routine blood draw. Stool sample through standard collection containers.

Also known as: Serum Samples, Stool Samples

Crohns Disease; Non-IBD; Ulcerative Colitis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• AbbVie: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum: Will be obtained from whole blood Stool: will be collected using standard collection containers and procedures and aliquoted Breath: Subjects will be nil per orally (NPO) for 8 hours prior to breath collection and they will rinse their mouths and gargle with water immediately before obtaining the breath sample to eliminate contamination from oral VOCs

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Florian Rieder, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 1, 2021
• Study Start: March 22, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

US (1)