UMIN-CTR Study Design: trial Number: R000016846.

Background:Bovine colostrum (BC) has direct antimicrobial and endotoxin-neutralizing effects throughout the alimentary tract, as well as other bioactivities that suppress gut inflammation and promote mucosal integrity and tissue repair under various conditions related to tissue injury. The precise role of BC in respiratory and gastrointestinal (GI) infections in children is not well defined. The aim of this study was to evaluate the efficacy and tolerability of BC administration in preventing recurrent upper respiratory tract infections (URTI) and diarrhea in children.Methods:One hundred sixty children (aged 1–6 years) having recurrent episodes of URTI or diarrhea received BC for 4 weeks. The number of episodes of URTI, diarrhea, and frequency of hospitalization required for URTI and diarrhea occurring during the study period were assessed at weeks 8 and 24.Results:From a total number of 160 children, 81 patients (50.63%) were males. The mean age (± SD) was 3.65 (± 2.01) years. The mean (± SD) total number of infections was significantly decreased after BC therapy from 8.6 ± 5.1 at baseline to 5.5 ± 1.2 after 2 months (P < 0.001) and to 5.7 ± 1.6 after 6 months (P < 0.001). The mean (± SD) total number of URTI (P < 0.0001), number of episodes of diarrhea (P < 0.001), and number of hospital admissions (P < 0.001) were significantly decreased after BC therapy.Conclusion:BC is effective in the prophylaxis of recurrent URTI and diarrhea as it reduces the number of episodes and the hospitalization due to these infections. Results of this study suggest that BC could be provided as a therapeutic option for children with recurrent URTI and diarrhea.

This study is the first double-blinded RCT proving the efficacy of vitamin D3 in ASD patients. Depending on the parameters measured in the study, oral vitamin D supplementation may safely improve signs and symptoms of ASD and could be recommended for children with ASD. At this stage, this study is a single RCT with a small number of patients, and a great deal of additional wide-scale studies are needed to critically validate the efficacy of vitamin D in ASD.

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