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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000078
Receipt No. R000000114
Scientific Title Antibiotic Combination Therapy in Patients with Active Refractory Ulcerative Colitis: A Prospective Randomized Placebo-controlled Multicenter Study
Date of disclosure of the study information 2005/08/26
Last modified on 2012/11/30

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Basic information
Public title Antibiotic Combination Therapy in Patients with Active Refractory Ulcerative Colitis: A Prospective Randomized Placebo-controlled Multicenter Study
Acronym Antibiotic Combination Therapy in Patients with Active Refractory Ulcerative Colitis
Scientific Title Antibiotic Combination Therapy in Patients with Active Refractory Ulcerative Colitis: A Prospective Randomized Placebo-controlled Multicenter Study
Scientific Title:Acronym Antibiotic Combination Therapy in Patients with Active Refractory Ulcerative Colitis
Region
Japan

Condition
Condition Ulcerative Colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess whether an antibiotic combination therapy against Fusobacterium varium is effective and safe for relapsing and refractory ulcerative colitis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes symptom assessment, endoscopic and histological evaluations, laboratory findings
Key secondary outcomes the titers of antibody to F. varium and the F. varium density in the mucosa

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients in the treatment group receive an antibiotic combination consisting of amoxicillin 500mg tid, tetracycline 500mg tid, and metronidazole 250mg tid for two weeks.
Interventions/Control_2 patients in the control group recieve three kinds of placebo contained sugar.
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
15 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria chronic relapsing and refractory ulcerative colitis patients who have inflammatory colonic mucosa and who attend regular outpatient or inpatient clinics at the Department of Gastroenterology
Key exclusion criteria Patients are excluded if they have toxic megacolon, if they have allergy to penicillin, if they are pregnant, if they have serious liver or renal disease or if they have psychological disease. In addition, patients who have taken antibiotics within four weeks of study entry and have Clostridium difficle or other stool pathogens at entry are excluded.
Target sample size 210

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhiro Sato
Organization Juntendo University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3813-3111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshifumi Ohkusa
Organization Juntendo University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3813-3111
Homepage URL
Email ohkusa@med.juntendo.ac.jp

Sponsor
Institute Japan UC Antibiotics-therapy Study Group(JUCASG)
Institute
Department

Funding Source
Organization Department of Gastroenterology, Juntendo University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Nihon University,Iwate Medical University, Kyoto Central Hospital
Yamagata Central Hospital
Oita University, Tokyo Medical University
Toyama Medical & Pharmaceutical University, Showa University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2005 Year 08 Month 26 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The 2-week triple antibiotic therapy produced improvement, remission, and steroid withdrawal in
active UC more effectively than a placebo.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2003 Year 09 Month 16 Day
Date of IRB
Anticipated trial start date
2003 Year 10 Month 01 Day
Last follow-up date
2006 Year 07 Month 01 Day
Date of closure to data entry
2006 Year 08 Month 01 Day
Date trial data considered complete
2006 Year 09 Month 01 Day
Date analysis concluded
2006 Year 12 Month 01 Day

Other
Other related information Ohkusa T, Kato K, Terao S, Chiba T, Mabe K, Murakami K, Mizokami Y, Sugiyama T, Yanaka A, Takeuchi Y, Yamato S, Yokoyama T, Okayasu I, Watanabe S, Tajiri H, Sato N. Newly Developed Antibiotic Combination Therapy for Ulcerative Colitis: A Double-Blind Placebo-Controlled Multicenter Trial. Am J Gastroenterol. 2010 Aug;105(8):1820-9.

Management information
Registered date
2005 Year 08 Month 25 Day
Last modified on
2012 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000114

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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