Ulcerative colitis
Conditions
Interventions
Routine home-based fecal immunochemical test
Sponsors
Hiraoka Sakiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with ulcerative colitis 2. Maintained clinical remission for more than 6 months without any change in treatment 3. Negative fecal immunochemical test (hemoglobin level in stool < 50 ng/mL) 4. Patient has a plan to de-escalation of one drug (5-ASA, thiopurine, biologic agents, or JAK inhibitors) (de-escalation including drug dose reduction, prolongation of administration period, and discontinuation). 5. Patients between the ages of 18 and 80 years at the time of obtaining consent 6. Out-patients 7. Patients who are able to obtain written consent from the individual to participate in research of their own free will
Exclusion criteria
Exclusion criteria: 1. Patients who are maintained in remission with drugs that cannot undergo de-escalation 2. Patients who are expected to have difficulty with the home fecal immnochemical test measurement procedure 3. Other patients who are deemed inappropriate as research subjects by the principal investigator and subinvestigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse rate within 2 years after drug de-escalation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical relapse rate 2. Rate of relapse requiring an advanced level of treatment than the drug with de-escalation 3. Rate of re-escalation of drug de-escalation 4. Percentage of patients seen outside of appointments 5. Rate of hospitalization 6. Risk factors for relapse; duration of clinical remission, type of drug with de-escalation, etc.Intervention group only 7. Rate of continuation of home fecal immunochemical test measurement 8. Rate of negative results after positive home fecal immunochemical test | — |
Contacts
Public ContactToshihiro Inokuchi
Okayama University
Outcome results
None listed