Evaluation of the Live Biotherapeutic Product, Asymptomatic Bacteriuria Escherichia coli 2‐12, in Healthy Dogs and Dogs with Clinical Recurrent UTI

BACKGROUND: Antimicrobial resistance is an emerging problem. HYPOTHESIS/OBJECTIVE: To investigate the safety and efficacy of a live biotherapeutic product, ASB E. coli 2‐12 for UTI treatment. ANIMALS: Six healthy research dogs; nine client‐owned dogs with recurrent UTI. METHODS: Prospective noncontrolled clinical trial. For safety data, research dogs were sedated, a urinary catheter was inserted into the bladder; 10(10) CFU/mL of ASB E. coli 2‐12 was instilled. Urine was cultured on days 1, 3, and 8 post‐instillation and dogs were observed for lower urinary tract signs (LUTS). For client‐owned dogs, ASB E. coli 2‐12 was instilled similarly and urine cultures analyzed on days 1, 7, and 14 days postinstillation. RESULTS: No LUTS were noted in any of the 6 research dogs after ASB E. coli 2‐12 infusion. Pulse field gel electrophoresis (PFGE) studies confirmed the bacterial strains isolated matched that ASB E. coli 2‐12 strain. Four of the nine client‐owned dogs had complete or nearly complete clinical cures by day 14. Of these four dogs, 3 also had microbiologic cures at day 14; one of these dogs had subclinical bacteriuria (in addition to ASB E. coli 2‐12). Three of these four dogs had ASB E. coli 2‐12 isolated from their urine at day 14. With the exception of mild, temporary, self‐limiting, hyporexia in two dogs on the day of biotherapeutic administration, there were no major adverse effects. CONCLUSIONS AND CLINICAL IMPORTANCE: These results suggest ASB E. coli 2‐12 is safe and should be investigated in a larger controlled study evaluating clinical UTI in dogs.