Efficacy of an orally administered anti-diarrheal probiotic paste (Pro-Kolin Advanced) in dogs with acute diarrhea: A randomized, placebo-controlled, double-blinded clinical study

Nixon, Sophie L.; Rose, Lindsay; Muller, Annika T.

Dogs were included in the study if they were presented to the veterinary surgeon for acute diarrhea with an owner-reported episode of diarrhea on ≥1 occasions in the 24 hours before presentation to the veterinarian. The cause of diarrhea was not investigated. Dogs were excluded from the study if their clinical signs were deemed unsuitable for conservative management by the attending veterinary surgeon or if they had received antibiotic or probiotic treatment in the 4 weeks before Day 0 of the study. A full list of inclusion and exclusion criteria is presented in the Supporting Information S1. Ethical approval was obtained from an independent welfare representative of Charles River Laboratories (Tranent, UK). A sample size of 43 cases per group was required based on the primary objective of identifying a difference in equality of survival curves in the proportion of dogs being free from diarrhea on day 3 using a 2-sided log rank test with a significance level of P < .05 and power of 80%; therefore, a target of 50 cases per group was set. The sample size calculation was based on 80% of dogs in the ADPP group and 50% of dogs in the Placebo group being free from diarrhea on Day 3. One hundred forty-eight dogs that fulfilled the inclusion criteria and none of the exclusion criteria were enrolled in the study and randomly assigned to receive either the ADPP (ADPP group) or a placebo paste (Placebo group) in a ratio of 1 : 1. The ADPP was a paste for PO administration containing E. faecium 4b1707, Preplex prebiotic, combined kaolin and montmorillonite clay, psyllium, pectin, and beta glucan (PKA; Protexin Veterinary, Somerset, UK). The placebo was indistinguishable in packaging, appearance, and sensory properties from the ADPP to study personnel. The ADPP and placebo were dosed q8h according to the dogs' body weight on Day 0. Details of the ADPP and placebo composition and the dosing regimen can be found in Supporting Information S2. All dogs received concurrent treatment with a highly digestible diet (Hills i/d, Topeka, Kansas) in place of their usual food. Dogs were treated with both the PO administered paste and diet until the dog had either completed or was withdrawn from the study, up to a maximum of 10 days, with completion defined as the passage of 3 consecutive feces of normal consistency.