Safety and Efficacy of AST-120 in the Treatment of Antibiotic-Refractory Pouchitis
Status:
Terminated
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
This is an open-label pilot study in which all patients will receive AST-120 for 4 weeks.
Patients will discontinue antibiotics at study entry. They may continue other previously
prescribed treatments (e.g., probiotics and/or nutritional agents) at the discretion of the
study doctor. The purpose of the study is to assess whether the investigational medication
AST-120 will be a safe and effective treatment for the symptoms of pouchitis, a chronic
inflammatory condition, in patients whose symptoms have not responded well to antibiotics. An
initial group of 10 patients will be enrolled. If there are no serious side effects
associated with the study drug and at least 3 of the 10 patients respond, a second group of
10 patients may be enrolled. Patients will have clinic visits at the start of the study and
at week 4. Patients will be checked by phone on a weekly basis for symptom response,
compliance and development of side effects. Endoscopies will be performed at the start of the
study and at week 4 or early termination.