Trial Details
RecruitingBasic Information
| Clinical ID | c2317 |
|---|---|
| Identifier | ISRCTN11043249 |
| Trial Title | An observational study to assess the relationship between disease flare states and patient-reported health data, health data from a wearable activity tracker, and biomarker data obtained through a decentralized process in patients with inflammatory bowel disease |
| Trial URL | Visit Original Page |
Study Information
| Study Results | Yes |
|---|---|
| Conditions | Inflammatory Bowel Disease (IBD) Digestive System |
| Interventions | Cohort 1: Participants with ulcerative colitis (UC) will be asked to provide biological samples such as blood, stool, and saliva samples at regular intervals, complete daily, weekly, and bi-weekly surveys, and wear a study-provided Fitbit activity tracker 24 hours a day for approximately 12 months. Cohort 2: Participants with Crohn's disease (CD) will be asked to provide biological samples such as blood, stool, and saliva samples at regular intervals, complete daily, weekly, and bi-weekly surveys, and wear a study-provided Fitbit activity tracker 24 hours a day for approximately 12 months. |
Participant Information
| Sponsor | F. Hoffmann-La Roche Ltd |
|---|---|
| City | - |
| Country/Region | United States |
Enrollment Criteria
| Sex Requirement | ALL |
|---|---|
| Age Requirement | - |
Study Design
| Study Type | Observational |
|---|---|
| Phase | Not Available |
Time Information
| Start Date | 2025-04-24 |
|---|---|
| Primary Completion Date | - |
| Completion Date | 2024-01-31 |