CLF065 for Chronic Pouchitis

Inclusion criteria

• . Adult subjects aged 18-80 years, inclusive.
• . In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
• . The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
• . Diagnosis of pouchitis that is recurrent, defined by mPDAI score of ≥ 5 assessed as the average from 3 days immediately prior to Baseline endoscopy, and a minimum endoscopic subscore of 2 (outside the staple or suture line) with either:
• . The patient has a history of proctocolectomy and construction of an IPAA for ulcerative colitis at least one year before the Screening Visit.
• . The patient agrees that antibiotic therapy will be managed per investigator discretion in accordance with standard of care.
• . Patient agrees to taper any corticosteroid or budesonide starting by Week 4 of the study per guidelines below.
• . A male subject who is nonsterilized and sexually activity with a female partner of childbearing potential agrees to use a barrier method of contraception (e.g., condom with spermicide) from signing informed consent throughout the duration of the study.

Exclusion criteria