ACTIVE_NOT_RECRUITING

Volatile Organic Compounds (VOCs) in Active Inflammatory Bowel Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-03-22
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04827368

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed as having Crohn's Disease or Ulcerative Colitis
  2. * Aged 18-70 years.
  3. * Understands the language and signs an informed consent form.
  4. * Any disease location, except isolated upper GI Crohn's disease only
  5. * Any CD or UC disease activity.
  6. * Outpatients and inpatients
  7. * 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.
  1. * Status post colectomy
  2. * Status post diverting loop ileostomy or end ileostomy or colostomy
  3. * On antibiotics in the past 3 months or currently
  4. * Women (pregnant or breast feeding)
  5. * Subjects with concurrent chronic liver, renal, lung or metabolic disorders
  6. * Active malignancy
  7. * Bowel preparation at day of sample procurement
  8. * Isolated upper GI Crohn's disease only
  9. * Active disease on colonoscopy, but normal fecal calprotectin at inclusion
  10. * C diff. positive at time of inclusion (test to be obtained in routine clinical care).

Contacts and Locations

Principal Investigator

Florian Rieder, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

  • Florian Rieder, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-22
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2021-03-22
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • IBD, VOC

Additional Relevant MeSH Terms

  • IBD
  • Crohn Disease
  • Ulcerative Colitis