ulcerative colitis
Conditions
Interventions
placebo
metronidazole
metronidazole,amoxicillin
metronidazole,amoxicillin,tetracycline
Sponsors
Hokkaido University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: UC patients who fits these condition. (1)Moderate to severe ulcerative colitis(Mayo score the bleeding sub-score from more than 6 and the rectum 1 more than) (2)In the screening endoscopy check day,patients fit at least 1 condition(1~4). 1 Patient who use 5-ASA(included SASP)more than 14 days. 2 Patient who use prednisolone below the 30mg/day for more than 14 days. 3 Patient who use AZA or 6-MP for more than 56 days. 4 Patient who use IFX or ADA for more than 56 days. (3)In the agreement day,the patient who has passed for more than 84 days after who diagnosed as UC. (4)In the agreement day,the patient who is more than 16 years old and less than 80 years old.
Exclusion criteria
Exclusion criteria: The patients who fit under one of them conditions is excluded. (1)Patient who has allergy in metronidazole,amoxicillin,tetracycline. (2)Patient who is infectious mononucleosis.(3)Patient who has a qualitative disease in a brain and a spinal cord.(4)Severe stricture colon.(5)Patient who has operation of large intestines.(Except for appendicitis.)(6)Patient who is a right or segmental colitis and/or acute fluminant colitis. (7)Patient who is a infection colitis. (8)The general cultivation check positive and/or a CD toxin positive and/or a parasite eggs in feces is a positive. (9)Patient with a heart disease(over NYHA3),liver disease,kidney disease. (10)Pregnant woman, lactating woman and the person who becomes pregnant. (11)Patient with perforation of large intestines. (12)The patients who fit under one of them conditions is excluded. 1.Prohibited combination use. 1)56 days before at the time of a screening endoscopy check day to 12 weeks later or cessation of all test. (cyclosporine, tacrolimus, methotrexate,Cytapheresis(Leukocyte Apheresis) 2)From 12 weeks before to cessation of all test. (Operation of large intestines) 3)From 14 days before at the time of prescription start date to the prescription end date. (antibacterial drug, antiviral drug,antifungal drug) 4)2.Restricted combination use. (13)Patient who can't collect information including steroid treatment in medical record.(14)In the agreement day,patient who participates in other clinical trials.(15)In the screening endoscopy check day,patient who was taking other clinical trial medicine within 84 days.(16)Patient who can't stop drinking an alcohol during taking clinical trial medicine. (17)Histoey of tic combination therapy(ATM/AFM treatment therapy) (18)Patient who has the medical history of the malignant tumor in the past for 5 years.(Except for basal-cell carcinoma of skin and uterine cervical carcinoma in situ.)(19)Patient that physician determined inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate after 12 weeks(Mayo score) . When it is these condition. (1)The Mayo score decreases more than 30 % and, more than 3 decreases. (2)The bleeding sub-score from the rectum is more than 1 decrease or less than 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Remission rate after 12 weeks(Mayo score) (2)Response rate and remission rate after 12 weeks(Mayo score) with refractory/inrefractory (3)Endoscopic remission rate after 12 weeks(mucosal healing) | — |
Countries
Japan
Contacts
Public ContactNao Horie
Hokkaido University Hospital Clinical research and Medical innovation Center
Outcome results
None listed