CRA Active Studies
Pilot Study of Automated Endoscopic Assessment in Patients with Ulcerative Colitis and Crohn's Disease
PI: Ryan Stidham (University of Michigan)
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.
MASCC: Multicenter Acute Severe Ulcerative Colitis Cohort Study
PI: Ashwin Anathakrishnan (Mass General Hospital) & Joanna Peloquin Melia (Johns Hopkins Medicine)
This is a large multi-center cohort of patients with acute severe colitis (ASUC) with homogeneously collected detailed longitudinal clinical and laboratory data. To our knowledge, this will be the first of its kind in the United States, and will be a key resource to understand the natural history, risk stratify and optimize therapeutic algorithms for care of patients with ASUC. An optional biospecimen arm of the study can be utilized for translational research into mechanisms of lack of response and development of biomarkers.
The ICON Study: Inflammatory Bowel Disease and Recurrent Clostridium Difficile Infection: Outcomes after Fecal Microbiota Transplantation
PI: Jessica Allegretti (Brigham and Women's Hospital)
The goal of this study is to prospectively study the clinical and microbial outcomes of FMT in patients with IBD-CDI. The overall objective of our study is to collect robust data and create a tissue and data repository to understand the effects FMT has on this unique subgroup of IBD patients during initial follow up using clinical and microbiome analyses. Our central hypothesis is that FMT is effective for the treatment of recurrent CDI in patients with IBD and FMT will not lead to adverse IBD outcomes in a majority of patients. The following aims will allow us to test the hypothesis and investigate the therapeutic potential of this targeted treatment.
The following aims will allow us to test the hypothesis and investigate the therapeutic potential of this targeted treatment for recurrent CDI in patients with IBD.
Specific Aim 1: Assess the efficacy of FMT at eradicating CDI in patient with IBD-CDI
Specific Aim 2: Assess IBD clinical outcomes post FMT
Specific Aim 3: Determine the impact of FMT on the intestinal microbiome of patients with IBD-CDI via 16s ribosomal RNA sequencing