A double‐blind, placebo‐controlled evaluation of orally administered heat‐killed Enterococcus faecalis FK‐23 preparation in atopic dogs

Abstract

Background -Gastrointestinal microbiome modulation is reported to be an effective therapy to reduce the clinical signs of canine atopic dermatitis (cAD). The killed strain of Enterococcus faecalis FK-23 has been shown to reduce allergic responses in mice and people.Hypothesis/Objective -The aim of this multicentre, double-blinded, placebo-controlled study was to evaluate the safety and efficacy of an orally administered heat-killed E. faecalis FK-23 preparation (FK-23p) for the control of cAD.Animals -Thirty-nine client-owned dogs with clinical signs of nonseasonal cAD were enrolled by 10 veterinarians at 15 hospitals.Methods and materials -Dogs were randomized to either FK-23p at a dose of ≥100 mg/kg/day or placebo. Owner-assessed pruritus Visual Analog Scale (pVAS), clinician-assessed Canine Atopic Dermatitis Extent and Severity Index, 4 th iteration (CADESI-4) and daily medication scoring (DMS) were evaluated on days 0, 28, 56 and 84. Owners and clinicians were interviewed about the overall response to treatment (RTT), after the study.Results -The CADESI-4 significantly decreased in the FK-23p group compared to the placebo group, by Day 84 (P = 0.035; Wilcoxon-Mann-Whitney U-test). There was no significant difference in pVAS and DMS between the groups. Owners and clinicians reported significantly better RTT in the FK-23p group than the placebo group (P = 0.043 and 0.002, respectively; Wilcoxon-Mann-Whitney U-test). There were no adverse events associated with FK-23p.Conclusions and clinical importance -Oral administration of FK-23p provided a small, but measurable benefit when used as an adjunct treatment, in reducing clinical signs of atopic dogs.

Impact of Nutritional Supplementation on Canine Dermatological Disorders

“…A body of research is directed toward the evaluation of heat-killed bacteria registered strains. The hypothesized mechanisms by which these bacteria may potentially influence AD symptoms is the modulation of the gastrointestinal microbiome, even if it is not fully elucidated [86,87]. Moreover, there are no data on the possible presence of a cutaneous-intestinal microflora axis and if this can be mutually influenced.…”

Pilot evaluation of Enterococcus faecium SF68 as adjunctive therapy for oclacitinib‐responsive adult atopic dermatitis in dogs

“…However, a dose greater than 100 mg/kg/d heat‐inactivated Enterococcus faecalis FK23p reportedly produced only a small benefit (Osumi et al . ). Human studies report benefit on doses ranging from 4×10 10 CFU/d (Kalliomäki et al .…”

“…Firstly, the small sample size could preclude detection of any but very large effects. Secondly, no optimum dose has been determined for (Osumi et al 2019). Human studies report benefit on doses ranging from 4×10 10 CFU/d (Kalliomäki et al 2001, Notay et al 2017 to 20.7 mg/kg/day (Inoue et al 2014).…”

A proposed medication score for long‐term trials of treatment of canine atopic dermatitis sensu lato

“…To the best of our knowledge, until now, nonvalidated, arbitrary MS scales have been used in eight published clinical trials of treatment of canine AD. [7][8][9][10][11][12][13][14] Seven of these scales do not include one or more of the medications that had been administered to the 35 dogs with AD, namely oral ciclosporin, 7,8 oral oclacitinib, [7][8][9][10][11]14 and topical 0.0584% hydrocortisone aceponate. 7,8,13 The only scale that included all these medications was MS-F'18.…”

“…In a few trials, a more precise evaluation of the influence of concurrent medications was attempted using medication scores (MS). [7][8][9][10][11][12][13][14] However, these scores differed in the permitted medications, the time period for which the MS was calculated (the whole duration of the trial or a defined time period before patient assessments) and in the arbitrary score assigned to each medication.…”