Current therapies for inflammatory bowel disease (IBD) are aimed at immune suppression. These have not prevented disease progression for the majority of IBD patients and come with consequent risk. There is a recognized need for new, safe and effective treatment for IBD. QBECO is a novel microbial-based immunotherapy designed to stimulate the immune response to overcome immune dysfunction in the gastrointestinal tract. QBECO has previously shown promising results in a randomized double-blind placebo controlled phase 2 clinical trials in Crohn’s disease (CD; NCT01809275).