Berberine Chloride in Preventing Colorectal Cancer in Patients With Ulcerative Colitis in Remission

PRIMARY OBJECTIVES: I. To determine the safety of berberine (berberine chloride) administered to participants with ulcerative colitis (UC) in clinical remission while receiving maintenance therapy with mesalamine. SECONDARY OBJECTIVES: I. Determine the molecular efficacy of berberine by examining the following biomarkers: * Plasma-based measures of inflammation, including the blood C-reaction protein (CRP) level, erythrocyte sedimentation rate (ESR), and cytokines such as TNFa, IL-4, IL-6, IL-8 and IL-10 measured by enzyme-linked immunosorbent assay (ELISA). * Tissue-based measures of inflammation, including TNFα, COX-2, and NF-kappa (κ)B by immunohistochemistry (IHC), and anti-cancer action, including antigen Ki-67 (Ki67) and activated caspase-3 by IHC, and deoxyribonucleic acid (DNA) methylation on SFRP1, TCERG1L FBN2, TFPI2 using the methylation-specific polymerase chain reaction (qMSP) strategy. II. Clinical efficacy: UC related symptoms will be measured using the Ulcerative Colitis Disease Activity Index (i.e. the Mayo score) (UCDAI). III. Histological analysis for inflammation: severity of histologic inflammation will be evaluated using the Geboes grading system. IV. Determine plasma concentration of berberine. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive berberine chloride orally (PO) thrice daily (TID) for 90 days in the absence of disease progression or unacceptable toxicity. ARM II: Participants receive placebo PO TID for 90 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are follow-up for 30 days.