UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of randomized trials of antibiotic combination therapies for patients with ulcerative colitis
Title of the study (Brief title)	Antibiotics trials for ulcerative colitis
Region	Japan

Condition
Condition	Ulcerative colitis
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	A randomized controlled trial comparing two antibiotic regimens for ulcerative colitis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase III

Assessment
Primary outcomes	Clinical remission and clinical response
Key secondary outcomes	Treatment failure rate

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	One group is to receive two-week combination therapy consisting of amoxicillin (Sawacillin) 500 mg t.i.d, tetracycline (Acromycin) 500 mg t.i.d, and metronidazole (Flagyl) 250 mg t.i.d. with an inhibitor of gastric acid secretion. Patients are to be followed for 3 months (first endpoint).
Interventions/Control_2	Another group will receive two week combination therapy consisting of amoxicillin (Sawacillin) 500 mg t.i.d, fosfomycin (Fosmicin) 1000mg t.i.d, and metrozole (Flagyl) 250 mg t.i.d, with an inhibitor of gastric acid secretion. Patients are to be followed for 3 months.
Interventions/Control_3
Interventions/Control_4
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Eligibility criteria for study entry are mild-to-severe, chronically relapsing UC and a Lichtiger Clinical Activity Index of at least 6 or a Mayo score of more than 5. 2) Patients able to visit the hospital during follow up 3) Cases whose doctors decided that they would be able to provide adequate answers during an interview 4) Patients providing informed consent.
Key exclusion criteria	1) Patients with diarrhea and fever, unable take the medications and those with toxic megacolon 2) Patients allergic to penicillin 3) Patients allergic to SASP and 5-ASA 4) Pregnant patients. Cases with complications of other severe diseases, such as renal and hepatic disorders. 5) Patients with mental disorders, and so on, considered by their doctors to be unsuitable candidates for clinical trials
Target sample size	40

Research contact person
Name of lead principal investigator	Kimitoshi Kato
Organization	Nihon University School of Medicine, Itabshi Hospital
Division name	Division of Research Planning and Development
Address	30-1 Oyaguchi-Kami machi, Itabashi-ku, Tokyo
TEL	03-3972-8111
Email	katou.kimitoshi@nihon-u.ac.jp

Public contact
Name of contact person	Kimitoshi Kato
Organization	Nihon University School of Medicine, Itabshi Hospital
Division name	Division of General Medicine, Dept. of Internal Medicine
Address	30-1 Oyaguchi-Kami machi, Itabashi-ku, Tokyo
TEL	03-3972-8111
Homepage URL
Email	katou.kimitoshi@nihon-u.ac.jp

Sponsor
Institute	Division of General Medicine, Department of Internal Medicine, Nihon University School of Medicine
Institute
Department

Funding Source
Organization	Division of General Medicine, Department of Internal Medicine, Nihon University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

Institutions
Institutions	日本大学医学部附属板橋病院

Other administrative information
Date of disclosure of the study information	2013 Year 01 Month 21 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 12 Month 17 Day
Anticipated trial start date	2013 Year 01 Month 23 Day
Last follow-up date	2018 Year 08 Month 30 Day
Date of closure to data entry	2018 Year 12 Month 30 Day
Date trial data considered complete	2018 Year 12 Month 30 Day
Date analysis concluded	2019 Year 03 Month 20 Day

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

Management information
Registered date	2013 Year 01 Month 19 Day
Last modified on	2018 Year 11 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011096