Alkaline phosphatase (ALP) is often elevated in patients with PSC and is used as a biomarker to assess response to therapies. The SHIP (Sulfasalazine Hidden in Plain Sight) study is a multicenter, randomized, double-blinded, placebo-controlled trial to evaluate sulfasalazine—an FDA-approved medication for arthritis and colitis—as a treatment for PSC. The study will determine if sulfasalazine can lower levels of ALP and other biomarkers of liver injury in PSC, whether it improves symptoms for patients, and whether they can take the medication safely. The SHIP study launched in late 2018 and is currently recruiting participants at ten sites across the country. The study should be completed in 2021.
Impact of dietary changes on PSC
In collaboration with Christopher L. Bowlus, MD, a national leader in PSC research from the University of California, Davis, the Resnek Family Center has launched a pilot study to evaluate the impact of dietary changes on PSC. The study involves 20 patients with PSC at BWH and UCD. Half the patients will eat a vegan diet, which emphasizes plant-based foods and eliminates all animal products such as meat, eggs, and dairy. The other half will eat a paleolithic diet, which includes lean meats, fish, fruits, vegetables, nuts, and seeds, and eliminates dairy products, legumes, and grains. Preliminary evidence suggests that both diets could benefit patients with PSC in different ways. This study will provide valuable new insights.
Biorepositories and observational studies
Much research remains to be done on the causes of PSC and how we can more effectively treat it. The rarity of the disease typically impedes researchers from identifying eligible subjects for a study and having access to patient samples. In collaboration with Dan Pratt, MD, from Massachusetts General Hospital, we've established a PSC data registry and biobank in an effort to accelerate research efforts into the disease.
This database is focused on gathering as much information on patients as possible to eventually facilitate research in this area. In addition, the tissue collected and stored in the repository will provide future researchers with material to study. As the samples will be stored for as yet undefined uses, the types of research expected are genetic, proteomic, and metabolomic analyses.