Stopped: This decision has been made after careful consideration and evaluation of trial progress and ongoing recruitment challenges.
The purpose of this study is to evaluate the reliability and responsiveness of symptoms, endoscopic, and histological items for assessing pouchitis disease activity in patients undergoing standard of care (SOC) antibiotic therapy for treatment of pouchitis, in order to develop a novel pouchitis disease activity index.
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Change from Screening Clinical Global Impressions of Severity at Week 6
Timeframe: Baseline and Week 6
Change from Screening Patient's Global Impression of Severity at Week 6
Timeframe: Duration of study, approximately 6 weeks.
Symptoms and Impacts Questionnaire for Pouchitis
Timeframe: Duration of study, approximately 6 weeks
Visual Analog Scale for Pouchitis Symptoms
Timeframe: Duration of study, approximately 6 weeks
Visual Analog Scale of Fecal Urgency
Timeframe: Duration of study, approximately 6 weeks
Visual Analog Scale of Abdominal Cramps Severity
Timeframe: Duration of study, approximately 6 weeks
Change from Baseline St. Mark's Fecal Incontinence Score (Vaizey Score) at Week 6
Timeframe: Baseline and Week 6
Endoscopic Disease Activity
Timeframe: Week 6
Histologic Disease Activity
Timeframe: Week 6