Multiple oral antibiotics therapy for induction and maintenance of ulcerative colitis
Not Applicable
- Conditions
- lcerative colitis
- Registration Number
- JPRN-UMIN000053277
- Lead Sponsor
- Juntendo University Graduate School of Medicine
- Brief Summary
The compliance rate was 95.7%. The response rate and remission rate were 75.2% and 30.9% at completion, 62.7% and 29.6% at 3 months, 48.2% and 27.7% at 6 months, 37.9% and 24.4% at 9 months, 35.4% and 24.4% at 12 months, respectively. The most frequent adverse events were diarrhea and fever. No life-threatening adverse events were observed during the trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 320
Inclusion Criteria
Not provided
Exclusion Criteria
Exclusion criteria were penicillin allergy, administration of antibiotics agents within 2 weeks of study entry, ongoing biologic therapy, pregnancy, cancer and other serious comorbid illness. Patients who had stool pathogens including Clostridium difficile, Salmonellae, pathogenic Escherichia coli were also excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint was the remission rate at 3 months after the completion of ATM therapy.
- Secondary Outcome Measures
Name Time Method