ulcerative colitis
Conditions
Interventions
Bifidobacterium breve fermented milk
placebo
Sponsors
Public Health Research foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients who became worse in 96 weeks before the day of entering this study with event1),2),3)or4) 1)experienced bloody-stool for over 7days continously in 2 years - 4 weeks before that day 2)started 5ASA therapy, gained their doses or changed to another blands between 2 years - 4 weeks before that day 3)started LCAP,GCAP or adrenocorticoids therapy, gained their doses between 2 years - 12 weeks before that day 4)started immunomodulator, immunosuppressant or targeted therapy, gained their doses between 2 years - 12 weeks before that day (2)Patients who were diagnoised as remission in 4 weeks before that day (3)Patients who are over 20 and under 70 years old (4)Patients who made consent documents after informed this study properly
Exclusion criteria
Exclusion criteria: (1)Patients who are diagnoised as proktitis by endoscope in nearly the day of entering this study (2)experienced bloody-stool in 4 weeks before that day (3)changed doses of oral 5ASA therapy or changed to another blands in 4 weeks before that day (4)started rectal 5ASA or adrenocorticoid therapy in 4 weeks before that day (5)started oral or parenteral adrenocorticoid therapy in 4 weeks before that day (6)started LCAP or GCAP therapy in 4 weeks before that day (7)started immunomodulator therapy in 12 weeks before that day (8)started immunosuppressant therapy in 12 weeks before that day (9)started targeted therapy in 12 weeks before that day (10)use antubiotics for over 14 days in 4 weeks before that day (11)can not stop to take another probiotics during this study (12)take reguraly the same probiotics as the test sample in 10 days before that day (13)register another clinical trials (14)experienced colon excision (15)experienced hypersensitivities to proviotics (16)having serious hepatic or kidney disorder (17)having mental disorder obviously (18)having malignant tumor or experienced in 5 years before that day (19)female who are pregnant, possible to be pregnant or want to be (20)judged to be exclusive by investigators with another reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to event | — |
Countries
Japan
Contacts
Public ContactSATOKO INOUE
Public Health Research foundation Secretariat,Comprehensive Support Project for Clinical Research of Life-Related Disease
Outcome results
None listed