Northwestern University
Micronutrient deficiencies are common in ulcerative colitis (UC). Selenium deficiency is associated with worse disease outcomes including disease flares and need for surgery. Previous in vitro and in vivo studies demonstrated that selenium regulates colonic inflammation, and that selenium supplementation protects against DSS-induced colitis. In this proof-of-concept clinical trial, we aim to test the hypothesis that selenium supplementation in moderate to severely active UC patients will improve responsiveness to advanced therapy such as biologics and small molecules.
Ulcerative colitis (UC) is an immune-mediated inflammatory condition of the colon characterized by mucosal inflammation and bloody diarrhea. UC affects over 1 million Americans with a rapidly growing international prevalence. The primary driver of disease impact in UC is uncontrolled inflammation and disease flares with downstream effects related to disease complications, including lower quality of life, hospitalizations, surgery, and development of colon cancer. Micronutrients exert a critical influence on immune responses, and micronutrient deficiencies have been linked to immune mediated in…
Inclusion Criteria: * Known or newly diagnosed moderate to severe UC (as defined by the modified Mayo score of 5-9; confirmed by clinical, endoscopic, and/or histopathological evidence prior to screening as per standard of care) who are either being started on or are being switched to a different FDA approved advanced therapy * The acceptable list of advanced therapies is (anti-TNF, anti-IL23, anti-integrin). For example, anti-tumor necrosis factor - infliximab, adalimumab, golimumab, certolizumab; anti-IL12/23 - ustekinumab, mirikizumab, risakizumab, guselkumab; anti-integrin - vedolizumab…
Patients enrolled in the study will receive 200 mcg selenomethionine daily
The placebo group will be taking a placebo supplement once daily
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