THE PROP-RD Study: A Prospective Registry for the Study of Outcomes and Predictors in Pouchitis and Pouch-Related Disorders
PI: Edward Barnes (University of North Carolina at Chapel Hill)
Although the options for medical treatment of ulcerative colitis (UC) have continued to advance in the past several decades, approximately 20-35% of patients with UC will ultimately require a colectomy due to refractory disease or dysplasia. There exists the potential for multiple complications in the first year post surgery. Gaps exist in our understanding of the clinical course of pouchitis, including the response to treatment for acute pouchitis and the mechanisms and risk factors for recurrent pouchitis. Much of our understanding about the natural history of pouchitis and pouch-related disorders has been generated from select populations. A geographically diverse, multicenter, prospective registry of patients with pouchitis and pouch-related disorders would fundamentally change our ability to investigate these conditions. We will create a prospective registry of patients with pouch-related conditions to allow for longitudinal assessment of outcomes at 3, 6 and 12 months after enrollment. We intend to identify specific clinical predictors of a progressive or refractory disease course among patients with acute pouchitis, including non-response to antibiotic therapy. In patients with chronic pouch-related conditions, we will evaluate the response to biologic and small molecule therapies. In addition, we plan to assess the feasibility of a prospective, multicenter approach to the identification of microbiota signatures as potential predictors of response in the treatment of pouch-related conditions.