The Guidelines are based on the result of the working group amended by comments of the experts of the Standing Committee of Animal Nutrition. Concerning the trial design and the parameters of the efficacy studies for micro-organisms in animal categories dogs, cats and horses some requirements are stated. Requirements A. Location Trials have to be conducted in independent research institutes or other facilities accepted for animal experiment purposes. If possible, trials should be investigated at two different locations. Concerning the number of animals the capacity of institutes or other facilities to keep large groups of dogs, cats and horses has to be taken into account.
Experiments have to include control groups.
The number of animals has to be sufficient for statistical analysis of results. D. Adaptation and test period Adaptation and test periods have to be chosen according to the goal of the study in accordance with good experimental practice. E. Efficacy parameters All effects should be consistent in themselves, be able to meet accepted scientific standards of statistical and biological significance, be plausible in terms of the relationship between micro-organisms and observed results in target species. Specific data Parameters which are related to the probiotic action. This requirement may be assumed to be satisfied where trials conducted in accordance with these guidelines have demonstrated efficacy to the level of statistical significance.