Antibiotic Combination Therapy in Patients with Active Refractory Ulcerative Colitis: A Prospective Randomized Placebo-controlled Multicenter Study

UMIN ID: C000000078

Registered date:26/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Ulcerative Colitis
• Date of first enrollment: 2003/10/01
• Target sample size: 210
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: symptom assessment, endoscopic and histological evaluations, laboratory findings
• Secondary Outcome: the titers of antibody to F. varium and the F. varium density in the mucosa

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Japan UC Antibiotics-therapy Study Group(JUCASG)
• Secondary Sponsor: Nihon University,Iwate Medical University, Kyoto Central Hospital Yamagata Central Hospital Oita University, Tokyo Medical University Toyama Medical & Pharmaceutical University, Showa University
• Source(s) of Monetary Support: Department of Gastroenterology, Juntendo University School of Medicine