Inflammatory bowel disease Digestive System
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Confirmed Crohn’s disease or ulcerative colitis or IBDU (Lennard-Jones/Porto criteria) 59-60. 2. Clinical remission 3. More than 6 months since diagnosis with Crohn’s disease, ulcerative colitis or IBDU 4. More than 2 months since any change in therapy for Crohn’s disease, ulcerative colitis or IBDU 5. Aged six years or over at study entry 6. Written informed consent obtained from patient or parent/guardian
Exclusion criteria
Exclusion criteria: 1. Patient unwilling to take part in all aspects of the study 2. Unable to obtain written informed consent 3. Systemic corticosteroids (oral or intravenous) within the last two months 4. Thiopurines / methotrexate / biologic therapy started in the preceding two months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evidence of clinical flare determined by the patient answering “no” to the following question “Do you think your disease has been well controlled in the past 1 month?” at baseline and then monthly for 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Medication status will be reported by the patient directly (via a secure web portal) on a monthly basis for 24 months. Patients will be asked to record any changes to their drug regimen including dose alteration, addition of new medication, stop of medication. | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales