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Search / Trial NCT04827368

Volatile Organic Compounds (VOCs) in Active Inflammatory Bowel Disease

Launched by THE CLEVELAND CLINIC · Mar 30, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Ibd, Voc

ClinConnect Summary

This clinical trial is studying how certain chemicals in breath and stool, known as volatile organic compounds (VOCs), can help in understanding and diagnosing Inflammatory Bowel Disease (IBD), which includes conditions like Crohn's Disease and Ulcerative Colitis. These diseases can cause symptoms like diarrhea, abdominal pain, and fatigue. The goal is to find new, non-invasive ways to diagnose and track the progression of IBD, which could lead to better management and fewer complications for patients.

To participate in the trial, you need to be between the ages of 18 and 70 and have a confirmed diagnosis of Crohn's Disease or Ulcerative Colitis. The study is currently recruiting patients, including those who are in the hospital or visiting as outpatients. Participants will provide samples of blood, breath, and stool before their colonoscopy, a procedure used to examine the intestines. This collection of samples will help researchers learn more about the disease and improve future diagnostic methods. It's important to note that certain people, such as those who have had specific types of surgery or are currently on antibiotics, will not be eligible for this trial.

Gender

ALL

Eligibility criteria

  • 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).

About The Cleveland Clinic

The Cleveland Clinic is a renowned nonprofit academic medical center based in Cleveland, Ohio, recognized for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, the Cleveland Clinic leverages its multidisciplinary expertise and state-of-the-art facilities to conduct groundbreaking studies aimed at improving patient outcomes across a wide range of medical conditions. With a strong emphasis on patient-centered care, the institution fosters collaboration among researchers, clinicians, and patients to explore new treatments and therapies, contributing significantly to the global body of medical knowledge.

Locations

Cleveland, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Florian Rieder, MD

Principal Investigator

The Cleveland Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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