ulcerative colitis
Conditions
Interventions
None listed
Sponsors
Department of Inflammatory Bowel Disease, Division of Internal Medicine Hyogo College of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ulcerative colitis patients within three years after diagnosis. 2. Patients with ulcerative colitis in active who meet the following criteria in Mayo score. (1) Mayo score(Full):3-9 (2) Mayo index:Mucosa>=1 (3) Mayo index:Rectal bleeding>=1 (4) Mayo index:Physician's global assessment<=2 3. Ulcerative colitis patients who are going to include induction therapy by oral 5-aminosalicylic acid(5ASA),including patients who have been relapsed during maintenance therapy in oral 5ASA administration. 4. Patients aged 13 or older. 5. Patients who were able to provide written informed consent before being included this study. In the case the proxy provide written informed consent, the proxy should be a person judged capable of representing the intents and best interests of the patient.
Exclusion criteria
Exclusion criteria: 1. Patients who had been treated with topical therapy (enema, suppository) within one month at the study inclusion. 2. Patients who have been treating by oral steroid, immunomodulator,Immunosuppresser (Tacrolimus), Cytapheresis, Biologics in their clinical relapse phase within one month at the study inclusion. 3. Patients with Crohn's disease. 4. Patients with gastric ulcer. 5. Patients with history of intestinal surgery. 6. Patients with pathogenic bacterium in stool examined by stool culture inspection. 7. Patients with allergy to Mesalazine. 8. Patients with allergy to Salicylic acid. 9. Patients with severe renal failure: eGFR<30 mL/min/1.73 m*2. 10. Patients with severe liver failure: AST or ALT>3 times of the upper limit of normal. 11. Patients who have been included other clinical trial. 12. Patients who is determined inappropriate to include to this study by the investigator. *Clinically relapse is defined as the phase in SCCAI score increased from<=2 to 3>=.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in remission rate in study population with time. Clinical remission was defined as the status in SCCAI score<=2. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in response rate in study population with time.Clinical response was defined as the status in decrease in SCCAI score by>=2 points in comparison to initial SCCAI. 2.Change in SCCAI score in study population with time. 3.Adverse effect | — |
Countries
Japan
Contacts
Public ContactTakako Miyazaki
Hyogo College of Medicine Department of Inflammatory Bowel Disease, Division of Internal Medicine
Outcome results
None listed