Abstract
BACKGROUND/AIMS: Escherichia coli Nissle 1917 (EcN) alone therapy is as effective as mesalamine in inducing and maintaining remission in ulcerative colitis (UC). The efficacy and safety of EcN in combination with standard therapies have not been studied. This study examined the changes in the inflammation markers and symptoms following the additional administration of EcN to patients showing the clinical remission of UC. METHODS: UC patients who received EcN after being in clinical remission for more than 3 months at Kosin University Gospel Hospital between 2013 and 2018 were evaluated through the retrospective medical-record-based review. The partial Mayo score, fecal calprotectin (FC), BMI, hemoglobin, serum cholesterol, serum albumin levels, and the safety profiles were examined at 3rd and 6th months after initiating EcN. RESULTS: Ninety-four patients were included. After 3 months of treatment, there was no significant change in FC (156.3 μg/g to 141.1 μg/g) (p=0.653). On the other hand, partial Mayo score decreased significantly from 0.085 to 0.014 (p=0.025), and the bodyweight (p=0.001), BMI (p<0.001), hemoglobin (p=0.009), and cholesterol level increased (p=0.148). One patient (1.1%) experienced a serious adverse event with UC flare-up, and 14 patients (14.9%) discontinued EcN due to adverse events; all developed within 3 months. CONCLUSIONS: Additional administration of EcN to clinically remission-attained UC patients may improve the UC symptoms without changing the FC levels. EcN-associated adverse events develop within the early few weeks.