Introduction: Antibiotic-associated diarrhea (AAD) is a common adverse reaction to antibiotic treatment affecting up to 21% of children. The aim of the study is to evaluate whether bovine lactoferrin (bLf) might be used for AAD prevention.Materials and Methods: In this prospective, randomized, double-blind, placebo-controlled, single-center study, we enrolled 156 children aged between 1 and 18 years, treated with antibiotic due to acute respiratory or urinary tract infection. We randomly allocated children 1:1 to receive 100 mg of bLf or a placebo twice a day orally for the whole period of antibiotic therapy. The primary outcome was the occurrence of antibiotic-associated diarrhea during and up to 2 weeks after antibiotic therapy. The secondary endpoint was intravenous rehydration or antibiotic withdrawal due to diarrhea. We performed intention-to-treat analysis.Results: We included 150 patients in intention-to-treat analysis. AAD occurred in 16 of 75 (21.3%) patients in bLf group and in 7 of 75 (9.3%) individuals in placebo group [OR = 2.6, (95% CI: 1.01–6.84), p = 0.04]. Relative risk was 2.29 (95% CI: 0.89–5.88). The need for intravenous rehydration occurred in one patient in the placebo group (p = 0.3). We observed no adverse effects in neither of the groups.Discussion: The trial indicated that bLf is not effective in AAD prevention. The risk for AAD was higher in bovine lactoferrin group as compared with placebo. We registered the study protocol on ClinicalTrials.gov (NCT02626104).
THE OPERATIONAL STATUTORY INTERPRETATION IN THE CONTEXT OF POLYCENTRICISMThe paper analyses the notion of “polycentricism” of a legal system from the operational statutory interpretation perspective at two levels of discourse: the scientific one pertaining to the existing theories of statutory interpretation and the adaptive one pertaining to the statutory interpretation performed in the course of law application processes in the judicial domain. An argument is put forward that it is obvious that to a certain degree, statements formulated in particular circumstances within a framework of a theory of statutory interpretation are transferred to operational statutory interpretation practice. As a result, it is possible to analyse the degree of conformity between operational statutory interpretation and polycentric assumptions on two different planes, i. e. the degree to which the dominant contemporary theories of statutory interpretation take the assumptions of legal system’s “polycentricism” into account, and the degree to which if any these assumptions are subject to adaptation to influences from the statutory interpretation as performed in the course of law application processes in the judicial domain operativeness.
The article presents theoretical issues related to the interposition to Polish criminal procedure rules known as „prohibition of eating the fruit of the poisonous tree”. The study addressed the following issues: 1) the interpretation of the article 168a of the Code of Criminal Procedure in the version after 1 July 2015; 2) some of the issues related to the possible problems with applicaton of this rule, and 3) axiology and theoretical legitimacy of this regulation.
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