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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-C000000078
Enrollment
210
Registered
2005-08-26
Start date
2003-10-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Interventions

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

Sponsors

Japan UC Antibiotics-therapy Study Group(JUCASG)
Lead Sponsor
Nihon University,Iwate Medical University, Kyoto Central Hospital Yamagata Central Hospital Oita University, Tokyo Medical University Toyama Medical & Pharmaceutical University, Showa University
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
symptom assessment, endoscopic and histological evaluations, laboratory findings

Secondary

MeasureTime frame
the titers of antibody to F. varium and the F. varium density in the mucosa

Countries

Japan

Contacts

Public ContactToshifumi Ohkusa

Juntendo University School of Medicine Department of Gastroenterology

ohkusa@med.juntendo.ac.jp03-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026