Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a longitudinal, observational study that aims to identify the microbial and human molecular triggers of IBD flares via stool, saliva, and blood metatranscriptomes, whole blood proteome, and collected clinical metadata. This study is direct to participant and will not utilize clinical sites.
This is a longitudinal, observational study that aims to identify the microbial and human molecular triggers of IBD flares via stool, saliva, and blood metatranscriptomes, whole blood proteome, and collected clinical metadata. This study will last approximately 3 years and will recruit up to 1000 Crohn's Disease participants and up to 1000 Ulcerative Colitis participants that will participant in the study for approximately 12 months. Participants will be sent at home sample collection kits and a study survey each month. If the survey responses indicate a participant is in a flare, they will be sent a sample collection kit and survey on a weekly basis until the flare is over and the monthly schedule resumes. The objective of the data analysis is to identify microbial functions that are predictive of the onset of a flare.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulcerative Colitis (UC) | Individuals with an ICD-10 diagnosis of Ulcerative Colitis. | ||
| Crohn's Disease (CD) | Individuals with an ICD-10 diagnosis of Crohn's Disease. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Names of species | Species present in samples taken in IBD and IBD flare onset states. | 3 years |
| Number of species | Number of each species present in sample taken in IBD and IBD flare onset states. | 3 years |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The study population will be composed of up to 1000 Ulcerative Colitis participants and up to 1000 Crohn's Disease participants that are 18 years of age or older and that meet the inclusion criteria.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Momchilo Vuyisich | Viome | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Viome Life Sciences | Bothell | Washington | 98011 | United States |
Not provided
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| D043183 | Irritable Bowel Syndrome |
| D003967 | Diarrhea |
| D015746 | Abdominal Pain |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D003109 | Colonic Diseases, Functional |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D010335 | Pathologic Processes |