UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory study of antibiotics combination therapy for moderate to severe ulcerative colitis
Title of the study (Brief title)	Antibiotic combination therapy(amoxicillin,tetracycline,metronidazole) for refractory UC
Region	Japan

Condition
Condition	ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Assessment of safety and efficacy of antibiotics combination therapy for patients with ulcerative colitis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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.
Key secondary outcomes	(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)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	placebo
Interventions/Control_2	metronidazole
Interventions/Control_3	metronidazole,amoxicillin
Interventions/Control_4	metronidazole,amoxicillin,tetracycline
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key 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.
Key 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.
Target sample size	212

Research contact person
Name of lead principal investigator	Takehiko Katsurada
Organization	Hokkaido University Hospital
Division name	Endoscopy
Address	N14,W5,Kita-Ku,Sapporo,Hokkaido,Japan
TEL	011-706-7715
Email	tkatsu@amber.plala.or.jp

Public contact
Name of contact person	Nao Horie
Organization	Hokkaido University Hospital
Division name	Clinical research and Medical innovation Center
Address	N14,W5,Kita-Ku,Sapporo,Hokkaido,Japan
TEL	011-706-7735
Homepage URL
Email	nhorie@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW	2016年10月20日

Institutions
Institutions	医療法人徳洲会　札幌東徳洲会病院（北海道） 独立行政法人国立病院機構　函館病院（北海道） 東京慈恵会医科大学附属柏病院（千葉県） 東京慈恵会医科大学附属病院（東京都） 東京慈恵会医科大学葛飾医療センター（東京都） 国立研究開発法人　国立国際医療研究センター病院（東京都） 日本大学医学部附属板橋病院（東京都） 国立大学法人　富山大学附属病院（富山県） 国立大学法人　大分大学医学部附属病院（大分県） 公立大学法人　横浜市立大学附属病院（神奈川県） 国立大学法人　筑波大学附属病院（茨城県） 東京医科大学茨城医療センター（茨城県） 東海大学医学部附属八王子病院（東京都） 順天堂大学医学部附属順天堂医院（東京都） 北海道公立大学法人　札幌医科大学附属病院（北海道）

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 05 Day
Anticipated trial start date	2016 Year 12 Month 15 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 10 Month 21 Day
Last modified on	2018 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028221