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Phase I Trial of Berberine in Subjects with Ulcerative Colitis

The primary endpoint of this study was toxicity. Given that this was a chemoprevention study, adverse events of all grades were tracked. All adverse events resolved within the time frame of the study, except pancreatitis, which developed one week after treatment was stopped, and was still present at the one-month follow-up time point. No participants were removed from the study due to adverse events. Oral berberine was found to only deliver low nM concentrations to the blood. Berberine is shown to be well tolerated by Chinese with UC receiving mesalamine. Finally, berberine was shown to significantly decrease colonic tissue inflammation, as measured by the Geboes score. These findings warrant continued investigation of berberine as a potential cancer prevention agent for CRC.


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