Factors that influence clinical efficacy of live biotherapeutic products

Traditional probiotics are increasingly being used in a medical context. The use of these products as drugs is considerably different from the traditional use as food or food supplements, as, obviously, the target population is different (diseased versus healthy or at risk population). Besides the target population, also the regulatory context is different, mainly with respect to production, administration regime and type of clinical studies required. In this paper we will, besides the regulatory differences, focus on aspects that may impact the efficacy of a live biotherapeutic product (drug), especially in a clinical setting. The impact of the dosage seems to depend on the strain and the application and may follow some rationale. In contrast, information on the impact of the time of administration or diet, is often still lacking. The matrix and the use of protective measures may clearly have an impact on the survival and efficacy of the strain.