A study to assess the relationship between disease flare states and participant-reported health data, health data from a wearable activity tracker, and biomarker data in participants with inflammatory bowel disease (IBD)
- Conditions
- Inflammatory Bowel Disease (IBD)Digestive System
- Registration Number
- ISRCTN11043249
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 350
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method