Study of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an IPAA (PROF)
Trial Parameters
Brief Summary
The aim of this study is to assess the safety and preliminary efficacy of treatment with EXE-346, a live biotherapeutic, which may reduce bowel movement frequency in patients with an ileal pouch-anal anastomosis (IPAA) and lead to a higher quality of life.
Eligibility Criteria
Inclusion Criteria - Phase 1b Only 1. Subject is a male or female and is between the age of 18 to 70 years, inclusive, at screening. 2. Subject has had a documented pouchoscopy within 12 months prior to screening. 3. Subject or the subject's legally authorized representative is willing and able to provide written informed consent prior to the initiation of any study-related procedures. 4. Subject has an average daily bowel movement frequency of at least 10 bowel movements recorded during screening and has correctly completed at least 7 days of eDiary entries during the screening period (Days -13 to 0). Inclusion Criteria - Phase 2 Double-Blinded Part Only 1. Subject is a male or female and is aged 18 years or older at screening. 2. Subject is willing and able to provide written informed consent prior to the initiation of any study-related procedures. 3. Subject has an average daily bowel movement frequency of at least 10 bowel movements recorded during screening and has correctly compl