No abstract

Introduction: To investigate the effectiveness and the safety of a probiotic-mixture (Vivomixx®, Visbiome®, DeSimone Formulation®; Danisco-DuPont, Madison, WI, USA) for the treatment of infantile colic in breastfed infants, compared with a placebo. Methods: A randomized, double-blind, placebo-controlled trial was conducted in exclusively breastfed infants with colic, randomly assigned to receive a probiotic-mixture or a placebo for 21 days. A structured diary of gastrointestinal events of the infants was given to the parents to complete. Samples of feces were also collected to evaluate microbial content and metabolome using fecal real-time polymerase chain reaction (qPCR) and Nuclear magnetic resonance (NMR)-based analysis. Study registered at (NCT01869426). Results: Fifty-three exclusively-breastfed infants completed three weeks of treatment with a probiotic-mixture (n = 27) or a placebo (n = 26). Infants receiving the probiotic-mixture had less minutes of crying per day throughout the study by the end of treatment period (68.4 min/day vs. 98.7 min/day; p = 0.001). A higher rate of infants from the probiotic-mixture group responded to treatment (defined by reduction of crying times of ≥50% from baseline), on day 14, 12 vs. 5 (p = 0.04) and on day 21, 26 vs. 17 (p = 0.001). A higher quality of life, assessed by a 10-cm visual analogue scale, was reported by parents of the probiotic-mixture group on day 14, 7.1 ± 1.2 vs. 7.7 ± 0.9 (p = 0.02); and on day 21, 6.7 ± 1.6 vs. 5.9 ± 1.0 (p = 0.001). No differences between groups were found regarding anthropometric data, bowel movements, stool consistency or microbiota composition. Probiotics were found to affect the fecal molecular profile. No adverse events were reported. Conclusions: Administration of a probiotic-mixture appears safe and reduces inconsolable crying in exclusively breastfed infants.

In summer 2013, an excess of paediatric cases of haemolytic uraemic syndrome (HUS) in a southern region of Italy prompted the investigation of a community-wide outbreak of Shiga toxin 2-producing Escherichia coli (STEC) O26:H11 infections. Case finding was based on testing patients with HUS or bloody diarrhoea for STEC infection by microbiological and serological methods. A case–control study was conducted to identify the source of the outbreak. STEC O26 infection was identified in 20 children (median age 17 months) with HUS, two of whom reported severe neurological sequelae. No cases in adults were detected. Molecular typing showed that two distinct STEC O26:H11 strains were involved. The case–control study showed an association between STEC O26 infection and consumption of dairy products from two local plants, but not with specific ready-to-eat products. E.coli O26:H11 strains lacking the stx genes were isolated from bulk milk and curd samples, but their PFGE profiles did not match those of the outbreak isolates. This outbreak supports the view that infections with Stx2-producing E. coli O26 in children have a high probability of progressing to HUS and represent an emerging public health problem in Europe.

According to international guidelines, healthcare workers and medical students immunized against HBV are periodically tested for anti-HBs IgG. Subjects who show an anti-HBs titre <10 mUI/mL must receive additional vaccine doses to induce a measurable antibody response. This study aimed to evaluate the long-time immunogenicity of anti-hepatitis B vaccination in a sample of medical students and residents of the University of Bari who attended the Hygiene Department for biological risk assessment (April 2014-June 2017). The strategy for the management of nonresponder subjects was evaluated. A total of 3676 students and residents were invited for testing according to a standardized protocol. Anti-HBs IgG was tested for in 3140 (85.4%) subjects: 1174/3140 (37.7%) subjects were negative. 14.6% (128/808) of subjects who received the vaccine during their 12th year of life and 45.8% (1056/2305) of subjects immunized during the first year of life (P < 0.0001) were negative. 1005/1174 (85.6%) seronegative subjects received a booster dose, and 903/1005 (89.9%) were tested for anti-HBs 1 month after the booster dose: 82/903 (9.1%) subjects were still negative. Of these, 56/82 (68.3%) received 2 additional doses of vaccine and 52/56 (92.9%) were tested 1 month after the third dose: 50/52 subjects (96.2%) developed a positive titre. In conclusion, several medical students, immunized at birth or at young age against HBV, did not develop protective titres against the virus. Our management strategy (booster retest; for negative subjects, 2 doses and retest) seems consistent with the purpose of evidencing immunological memory.

In recent years, public health authorities in industrialized countries have noted an increase in the numbers of parents choosing not to have their children vaccinated and in the activities of 'antivaccination' movements. Doubts about vaccine safety and lack of surveillance of adverse events following immunization (AEFI) are the most frequent themes proposed by antivaccination movements. This editorial aims to critically analyze the use of AEFI assessment procedures among national health authorities and public health researchers. In fact, the WHO recommended and published a systematic and standardized causality assessment process for serious AEFI, providing a method for individual causality assessment to be used by staff of national immunization programs, regulatory authorities and pharmacovigilance or surveillance departments. The last update was published in March 2013 but to date, an Internet search reveals no information or reports on AEFI surveillance that uses the WHO AEFI causality assessment.