Volatile Organic Compounds (VOCs) in Active Inflammatory Bowel Disease

Study Overview
=================
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.

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

Conditions
-----------------
IBD, Crohn Disease, Ulcerative Colitis

Intervention / Treatment
-----------------
* Other: Breath Test


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Crohns Disease<br> | Other: Breath Test<br>* Research Breath Test<br>|
| Ulcerative Colitis<br> | Other: Breath Test<br>* Research Breath Test<br>|
| Non-IBD<br> | Other: Breath Test<br>* Research Breath Test<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breath volatile organic compounds (VOC)s and objective markers of Inflammatory Bowel Disease (IBD) Activity | Correlation of breath VOCs with changes in C-reactive protein (CRP) and clinical disease activity | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IBD, VOC