Patients receive berberine chloride PO TID for 90 days in the absence of disease progression or unacceptable toxicity.

Participants receive placebo PO TID for 90 days in the absence of disease progression or unacceptable toxicity.

Ulcerative Colitis

Berberine Chloride

Laboratory Biomarker Analysis

Placebo Administration

Northwestern University

Fourth Military Medical University

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

Phase I Trial of Berberine in Subjects With Ulcerative Colitis

Relevant counts and rates will be evaluated and reported. Symptoms such as fever, fatigue, weight loss, appetite, stool frequency, bloody stool and other upper and lower gastrointestinal tract symptoms in participants will be observed and recorded.

Evaluated by standard clinical tests. Symptoms such as fever, fatigue, weight loss, appetite, stool frequency, bloody stool and other upper and lower gastrointestinal tract symptoms in participants will be observed and recorded.

Descriptive statistics and graphical methods to present the evidence of possible correlations in outcomes of interest. Box plots and confidence intervals will be used to assign proper mass weight to groups of observations. "Before" and "after" intervention values and their difference will be compared with suitably chosen counterparts.

The Ki-67 and cleaved caspase 3 outcomes will be the number of cells positive over total number. The TNFa, COX-2, and NF-κB immunohistochemistry will be done by quantitation through chromovision and will be expressed as % of control (placebo, pre-treatment). Descriptive statistics and graphical methods will be performed to present the evidence of possible correlations in outcomes of interest.

The description and comparison of gene methylation status will be performed both with the view of before - after possible change within each treatment group, as well as with the view of treatment - control groups for before and for the after period. Descriptive statistics and graphical methods will be performed to present the evidence of possible correlations in outcomes of interest.

Histologic sections will be stained with hematoxylin and eosin and the severity of histologic inflammation will be evaluated using the Geboes grading system.

berberine chloride/inflammation

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

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