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Active, Not Recruiting

NCT Number: NCT04827368

Volatile Organic Compounds (VOCs) in Active Inflammatory Bowel Disease

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

IBD Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Breath Test

Other

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

Primary outcomes

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

    Time frame: 1 year

    Correlation of breath VOCs with changes in Fecal Calprotectin.

Secondary outcomes

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

    Time frame: 1 year

    Correlation of breath VOCs with changes in C-reactive protein (CRP) and clinical disease activity

Other outcomes

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

    Time frame: 1 year

    Correlation of breath VOCs with endoscopic disease activity

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • AbbVie

Registry information

Official study title

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

Acronym: VOC

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2021
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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