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Adjunctive use of E. coli Nissle failed to improve outcomes in active UC
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Adjunctive use of the probiotic Escherichia coli strain Nissle 1917 with conventional therapy did not appear to confer any benefit in patients with active ulcerative colitis, including greater clinical remission, according to recent findings.
In the single-center, double blind study, researchers in Denmark evaluated 100 patients with active ulcerative colitis (UC), as defined by a Colitis Activity Index (CAI) score of six or greater. Participants were randomly assigned 500 mg ciprofloxacin twice daily (n=25) or placebo (n=25) for 1 week, followed by 100 mg E. coli Nissle (EcN; n=25) daily for 4 days followed by 100 mg twice daily for the remainder of the period or placebo (n=25) for 7 weeks. All four regimens were administered as adjunctive therapy.
Researchers said the percentage of patients who achieved remission after being assigned placebo and EcN was smaller than among those patients receiving placebo followed by placebo (54% vs. 89%; P<.05). The group treated with ciprofloxacin followed by placebo had a 78% rate of remission compared with 66% for patients assigned ciprofloxacin followed by EcN. In addition, the placebo/EcN group had the greatest rate of patient discontinuation (44%) compared with 20% in any other group (P<.05).
Patients who underwent treatment with placebo and EcN exhibited a lack of mucosal healing, with only 29% of the patients who remained in the cohort reporting no bloody stools at week 12 (P<.02). By comparison 63% of patients in the ciprofloxacin/EcN group, 67% in the ciprofloxacin/placebo group, and 65% in the placebo/placebo group reported no blood in their stools.
“Our data suggest that there is no benefit in the use of E. coli Nissle as an add-on treatment to conventional therapies for active ulcerative colitis,” the researchers wrote. “Furthermore, treatment with E. coli Nissle without a previous antibiotic cure resulted in fewer patients reaching clinical remission.”
Disclosure: The researchers report no relevant financial disclosures.
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