Inflammatory Bowel Disease (IBD) Digestive System
Conditions
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 sur
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 01/08/2022: 1. Age of more than 18 years 2. Diagnosis of moderate-severe CD or UC by a healthcare provider via colonoscopy 3. One or more IBD flares in the previous 12 months, with a flare defined as an occurrence in an unplanned visit to a primary gastroenterologist or IBD specialist or the initiation of treatment to manage IBD or due to change in the medical management of IBD by a healthcare provider 4. The participant is a resident of the United States and can speak, read, and understand English 5. Agree to wear an activity tracker on the same wrist 24 hours a day (except when charging the tracker) for the duration of the study 6. Agreement to self-collect saliva and stool samples and store one stool sample in the freezer until pick-up at least every 4 weeks 7. Must have a smartphone that is compatible with the IBDoc CalApp (list of compatible devices is available at: https://www.ibdoc.net/support/?lang=en) and must be able to take an at-home stool test and upload results using a smartphone app every 2 weeks 8. Agreement and ability to store up to four sample kits in the refrigerator during the study 9. Agreement and ability to receive shipments at a mailing address that is not a post office box 10. Agreement and ability to have a mobile phlebotomist collect blood, stool, and saliva samples at home or at a place of their choosing at least every 4 weeks during phlebotomist business hours 11. Agreement to complete daily and weekly questionnaires _____ Previous inclusion criteria: 1. Age of more than 18 years 2. Diagnosis of moderate-severe CD or UC by a healthcare provider via colonoscopy 3. Two or more IBD flares in the previous 24 months, with a flare defined as an occurrence in an unplanned visit to a primary gastroenterologist or IBD specialist or the initiation of treatment to manage IBD or due to change in the medical management of IBD by a healthcare provider 4. The participant is a resident of the United States and can speak, read, and understand English 5. Agree to wear an activity tracker on the same wrist 24 hours a day (except when charging the tracker) for the duration of the study 6. Agreement to self-collect saliva and stool samples and store one stool sample in the freezer until pick-up at least every 4 weeks 7. Agreement to donate a blood sample for genome testing 8. Must have a smartphone that is compatible with the IBDoc CalApp (list of compatible devices is available at: https://www.ibdoc.net/support/?lang=en) and must be able to take an at-home stool test and upload results using a smartphone app every 2 weeks 9. Agreement and ability to store up to four sample kits in the refrigerator during the study 10. Agreement and ability to receive shipments at a mailing address that is not a post office box 11. Agreement and ability to have a mobile phlebotomist collect blood, stool, and saliva samples at home or at a place of their choosing at least every 4 weeks during phlebotomist business hours 12. Agreement to complete daily and weekly questionnaires
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 01/08/2022: 1.Has a diagnosis of ischemic/radiation colitis 2. Has a diagnosis of primary sclerosing cholangitis 3. Has a diagnosis of an abdominal abscess or perianal abscess requiring surgical intervention or antibiotic treatment within the past 3 months 4. Has a history of cancer, excluding non-melanoma skin cancer that was completely removed 5. Has a history of organ transplant 6. Diagnosis of, or treatment for, infectious colitis, such as CMV colitis or Clostridium difficile colitis, within the past 60 days 7. Hospitalization within the past 8 weeks 8. Participation in a treatment program for drug, alcohol, or chemical abuse in the past 6 months 9. Use of biologics for non-IBD conditions 10. Use of an immune-modulating medication treating a condition other than IBD or its complications 11. Planned IBD abdominal surgery 12. Participation in a clinical trial that involves blood draws, any treatment or procedure for IBD, or a change in IBD care within the past 3 months 13. Current participation in a clinical trial that involves blood draws, any treatment or procedure for IBD, or a change in regular IBD care, or intending to participate in such a trial within the next 12 months _____ Previous exclusion criteria: 1. Has a diagnosis of a non-IBD autoimmune condition 2. Has a diagnosis of indeterminate/ischemic/radiation colitis 3. Has a diagnosis of primary sclerosing cholangitis 4. Has a diagnosis of an abdominal abscess or perianal abscess in the past 2 years 5. For participants with CD: diagnosis of intestinal strictures or intestinal fistula 6. Has a history of cancer, excluding non-melanoma skin cancer that was completely removed 7. Has a history of organ transplant 8. Diagnosis of, or treatment for, infectious colitis, such as CMV colitis or Clostridium difficile colitis, within the past 60 days 9. Hospitalization within the past 8 weeks 10. Participation in a treatment program for drug, alcohol, or chemical abuse in the past 6 months 11. Use of biologics for non-IBD conditions 12. Use of an immune-modulating medication treating a condition other than IBD or its complications 13. Prior or scheduled IBD abdominal surgery 14. Participation in a clinical trial that involves blood draws, any treatment or procedure for IBD, or a change in IBD care within the past 3 months 15. Current participation in a clinical trial that involves blood draws, any treatment or procedure for IBD, or a change in regular IBD care, or intending to participate in such a trial within the next 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Distributional Differences in Biomarker Data Collected During IBD Flare State Versus Non-Flare State Measured Using Biological Samples over 52 Weeks 2. Distributional Differences in PRO Data Collected During IBD Flare State Versus Non-Flare State Measured Using Daily, Weekly, and Bi-Weekly Surveys over 52 Weeks 3. Distributional Differences in Activity Tracker Data Collected During IBD Flare State Versus Non-Flare State Measured Using Wearable Activity Tracker over 52 weeks 4. Within-Participant Changes in Biomarker Data Collected During IBD Flare State Relative to Non-Flare State Measured Using Biological Samples over 52 Weeks 5. Within-Participant Changes in PRO Data Collected During IBD Flare State Relative to Non-Flare State Measured Using Daily, Weekly, and Bi-Weekly Surveys over 52 Weeks 6. Within-Participant Changes in Activity Tracker Data Collected During IBD Flare State Relative to Non-Flare State Measured Using Wearable Activity Tracker over 52 Weeks 7. Within-Participant Variability Versus Between-Participant Variability in Biomarker Data Measured Using Biological Samples over 52 Weeks 8. Within-Participant Variability Versus Between-Participant Variability in PRO Data Measured Using Daily, Weekly, and Bi-Weekly Surveys over 52 Weeks 9. Within-Participant Variability Versus Between-Participant Variability in Activity Tracker Data Measured Using Wearable Activity Tracker over 52 Weeks 10. IBD Flare Detection Performance, Utility, and Feasibility for Biomarker Data Compared with Benchmark Flare Detectors Measured Using Biological Samples over 52 Weeks 11. IBD Flare Detection Performance, Utility, and Feasibility for PRO Data Compared with Benchmark Flare Detectors Measured Using Daily, Weekly, and Bi-Weekly Surveys over 52 Weeks 12. IBD Flare Detection Performance, Utility, and Feasibility for Activity Tracker Data Compared with Benchmark Flare Detectors Measured Using Wearable Activity Tracker over 52 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Longitudinal Trends in Biomarker Data Collected During the Time Leading up to IBD Flare Measured Using Biological Samples over 52 Weeks 2. Longitudinal Trends in PRO Data Collected During the Time Leading up to IBD Flare Measured Using Daily, Weekly, and Bi-Weekly Surveys over 52 Weeks 3. Longitudinal Trends in Activity Tracker Data Collected During the Time Leading up to IBD Flare Measured Using Wearable Activity Tracker over 52 Weeks 4. Within-Participant Variability in Biomarker Data During Non-IBD Flare State Measured Using Biological Samples over 52 Weeks 5. Within- Participant Variability in PRO Data During Non-IBD Flare State Measured Using Daily, Weekly, and Bi-Weekly Surveys over 52 Weeks 6. Within- Participant Variability in Activity Tracker Data During Non-IBD Flare State Measured Using Wearable Activity Tracker over 52 Weeks 7. IBD Flare Prediction Performance, Utility, and Feasibility for Biomarker Data Compared with Benchmark IBD Flare Predictors Measured Using Biological Samples over 52 Weeks 8. IBD Flare Prediction Performance, Utility, and Feasibility for PRO Data Compared with Benchmark IBD Flare Predictors Measured Using Daily, Weekly, and Bi-Weekly Surveys over 52 Weeks 9. IBD Flare Prediction Performance, Utility, and Feasibility for Activity Tracker Data Compared with Benchmark IBD Flare Predictors Measured Using Wearable Activity Tracker over 52 Weeks 10. Percentage of Days or Weeks with Completed Surveys Using IBDoc CalApp over 52 Weeks 11. Percentage of Days with Complete Activity Tracker Data Using Wearable Activity Tracker over 52 Weeks 12. Percentage of Scheduled Mobile Phlebotomist Visits that are Completed over 52 Weeks 13. Percentage of Scheduled IBDoc® At-Home Stool Calprotectin Tests that are Completed over 52 Weeks 14. Adherence to Survey Completion Using IBDoc CalApp over 52 Weeks 15. Adherence To Mobile Phlebotomist Visits over 52 Weeks 16. Adherence To IBDoc At-Home Stool Calprotectin Tests over 52 Weeks 17. Agreement Between | — |
Countries
United States of America
Contacts
Public ContactJennifer Damman
Outcome results
None listed