Additional Relevant Details
The Phase 2b/3 trial is a double-blind, placebo-controlled, three arm, multicenter study evaluating safety, efficacy and tolerability of two dosing regimens of its investigational compound RP-G28 in patients with moderate to severe lactose intolerance symptoms.  Enrollment was initiated in March of 2016 and completed within 6-months, achieving the company’s projected enrollment milestones.  The study aims to evaluate a patient’s ability to consume dairy foods post-treatment with improved tolerance and reduced digestive symptoms.  A total of 377 subjects were enrolled in the trial with 18 clinical sites participating throughout the United States.  Patients undergo a 30-day treatment, followed by a 30-day post-treatment evaluation of dairy tolerance.  In addition, the study will evaluate each participant’s microbiome, expanding knowledge of the effects that RP-G28 may have on adapting the gut microbiota in a beneficial manner.