ulcerative colitis
Conditions
Interventions
LCAP is determined to apply if patient does not obtain a significant improvement (higher than 50%) in spite of recieving sufficient steroid therapy (higher than 30mg/day of prednisolone) for 3 days.
L
Sponsors
Lower Gastroenterology, Hyogo College of Medicine
Department of Gastroenterology, Osaka City University and Department of Gastroenterology, Osaka Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The inclusion criteria in this study are as follows. Patients met all the criteria. 1)Patients with moderate to severe UC in active stage according to the UC severity criteria established by the Research Committee of Specified Diseases/Intractable Inflammatory Bowel Diseases of Ministry of Health, Labour and Welfare. 2)Patients with serum C-reactive protein level of 1.0mg/dL or higher. 3)Patients not having received any corticosteroids therapy, or having received the corticosteroids therapy less than 0.6mg/kg/day or 30mg/day or less, within the past 2 weeks.
Exclusion criteria
Exclusion criteria: 1) Patients with proctitis 2) Patients with chronic persistent UC 3) Patients having consecutively received corticosteroids therapy of 5mg/day or more, for more than 3 months 4) Patients having consecutively received corticosteroids enema therapy for more than 3 months 5) Patients with either white blood cell count of less than 3,000/mm3, or hemoglobin level of less than 10g/dL, or platelet count of less than 100,000/mm3 6) Patients who are younger than 12 years old or who are older than 80 years old. 7) Patients determined to be inappropriate for this study by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the improvement of Mayo score obtained after 6th LCAP. Mayo score is taken before (within 2 weeks of starting LCAP) and after 6th LCAP. Partial-Mayo score is taken at every visit and/or whenever the score has to be taken without endoscopic evaluation. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome is the Lichtiger's clinical activity index taken before (within 2 weeks of starting LCAP) and after 6th LCAP. | — |
Countries
Japan
Contacts
Public ContactKen Fukunaga
Hyogo College of Medicine Lower GI disease
Outcome results
None listed