Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| B19-566 | Other Identifier | Abbvie |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crohns Disease | Potential participants will be identified based on their planned/scheduled endoscopy visit. |
| |
| Ulcerative Colitis | Potential participants will be identified based on their planned/scheduled endoscopy visit. |
| |
| Non-IBD | Healthy subjects with no bowel disorders will be included as controls. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breath Test | Other | Research Breath sample through disposable mouth filter. Serum sample through routine blood draw. Stool sample through standard collection containers. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Breath volatile organic compounds (VOC)s and objective markers of Inflammatory Bowel Disease (IBD) Activity | Correlation of breath VOCs with endoscopic disease activity | 1 year |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
This is a prospective, controlled, non-interventional cohort study, conducted at the Cleveland Clinic IBD Center, using serially obtained breath and serum headspace VOCs as non-invasive biomarkers to detect disease activity in IBD, fecal calprotectin, CRP, and patient-reported outcome tools. No drug will be evaluated in this study. All visits for this study as well as the initial endoscopy will be based on standard clinical practice and guidelines.
At inclusion, all patients will have a colonoscopy (indication is standard of care), CRP, fecal calprotectin, and baseline PRO2 to establish the pattern for disease activity, which will subsequently be evaluated for change by using fecal calprotectin, CRP, and PRO2 over one year (every 3 months), as a surrogate marker for disease activity.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Florian Rieder, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
Not provided
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Serum: Will be obtained from whole blood Stool: will be collected using standard collection containers and procedures and aliquoted Breath: Subjects will be nil per orally (NPO) for 8 hours prior to breath collection and they will rinse their mouths and gargle with water immediately before obtaining the breath sample to eliminate contamination from oral VOCs
|
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |