Unique ID issued by UMIN | C000000078 |
---|---|
Receipt number | 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 00:32:07 |
Antibiotic Combination Therapy in Patients with Active Refractory Ulcerative Colitis: A Prospective Randomized Placebo-controlled Multicenter Study
Antibiotic Combination Therapy in Patients with Active Refractory Ulcerative Colitis
Antibiotic Combination Therapy in Patients with Active Refractory Ulcerative Colitis: A Prospective Randomized Placebo-controlled Multicenter Study
Antibiotic Combination Therapy in Patients with Active Refractory Ulcerative Colitis
Japan |
Ulcerative Colitis
Gastroenterology |
Others
NO
To assess whether an antibiotic combination therapy against Fusobacterium varium is effective and safe for relapsing and refractory ulcerative colitis
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
symptom assessment, endoscopic and histological evaluations, laboratory findings
the titers of antibody to F. varium and the F. varium density in the mucosa
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
YES
Institution is considered as a block.
YES
Central registration
2
Treatment
Medicine |
Patients in the treatment group receive an antibiotic combination consisting of amoxicillin 500mg tid, tetracycline 500mg tid, and metronidazole 250mg tid for two weeks.
patients in the control group recieve three kinds of placebo contained sugar.
15 | years-old | <= |
70 | years-old | >= |
Male and Female
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
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.
210
1st name | |
Middle name | |
Last name | Nobuhiro Sato |
Juntendo University School of Medicine
Department of Gastroenterology
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
03-3813-3111
1st name | |
Middle name | |
Last name | Toshifumi Ohkusa |
Juntendo University School of Medicine
Department of Gastroenterology
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
03-3813-3111
ohkusa@med.juntendo.ac.jp
Japan UC Antibiotics-therapy Study Group(JUCASG)
Department of Gastroenterology, Juntendo University School of Medicine
Self funding
Japan
Nihon University,Iwate Medical University, Kyoto Central Hospital
Yamagata Central Hospital
Oita University, Tokyo Medical University
Toyama Medical & Pharmaceutical University, Showa University
NO
2005 | Year | 08 | Month | 26 | Day |
Published
The 2-week triple antibiotic therapy produced improvement, remission, and steroid withdrawal in
active UC more effectively than a placebo.
Completed
2003 | Year | 09 | Month | 16 | Day |
2003 | Year | 10 | Month | 01 | Day |
2006 | Year | 07 | Month | 01 | Day |
2006 | Year | 08 | Month | 01 | Day |
2006 | Year | 09 | Month | 01 | Day |
2006 | Year | 12 | Month | 01 | Day |
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.
2005 | Year | 08 | Month | 25 | Day |
2012 | Year | 11 | Month | 30 | Day |
Value
https://center6.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 |