Exploratory study of antibiotics combination therapy for moderate to severe ulcerative colitis - Antibiotic combination therapy(amoxicillin,tetracycline,metronidazole) for refractory UC

Hokkaido University Hospital0 sites212 target enrollmentOctober 22, 2016

Conditionsulcerative colitis

Overview

Phase: 未知
Intervention: Not specified
Conditions: ulcerative colitis
Sponsor: Hokkaido University Hospital
Enrollment: 212
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 22, 2016

End Date

March 31, 2018

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Hokkaido University Hospital

Eligibility Criteria

Inclusion Criteria

Not provided

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.