Crohn Disease, IBD, Ulcerative Colitis
Conditions
Keywords
IBD, VOC
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.
Interventions
OTHERBreath Test
Research Breath sample through disposable mouth filter. Serum sample through routine blood draw. Stool sample through standard collection containers.
Sponsors
The Cleveland Clinic
AbbVie
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breath volatile organic compounds (VOC)s and objective markers of Inflammatory Bowel Disease (IBD) Activity | 1 year | Correlation of breath VOCs with changes in Fecal Calprotectin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breath volatile organic compounds (VOC)s and objective markers of Inflammatory Bowel Disease (IBD) Activity | 1 year | Correlation of breath VOCs with changes in C-reactive protein (CRP) and clinical disease activity |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFlorian Rieder, MD
The Cleveland Clinic
Outcome results
None listed