Primary care experience on Stimunex® gocce in children with recurrent respiratory infections: a real-world study during the COVID-19 pandemic era.

BACKGROUND: Respiratory infections (RI) significantly burden society, mainly when there are recurrent respiratory infections (RRI). Thus, there is a need to prevent RI in clinical practice. In this regard, the modulation of the immune system and resolution of the inflammatory cascade could represent an ideal way to prevent RI. Stimunex® gocce, a multicomponent food supplement, contains Sambucus nigra extract, ß-glucan, Zinc, and Vitamin D3. This study investigated its ability to prevent RRI in children using a real-world setting: the pediatric primary care. MATERIALS AND METHODS: Two hundred and ninety-eight children with RRI were enrolled in the current study. The food supplement was randomly prescribed to 160 children with RRI daily for 4 months (Active group); the remaining 138 children with RRI were treated only with standard therapy for RI (Control group). The number and duration of RI, parental perception of symptom severity and treatment efficacy, use of medications, and school and working absence were evaluated. RESULTS: Children treated with Stimunex® gocce had significantly less RI than the Control group, both concerning upper and lower RI (p˂0.001 and 0.003, respectively) during the follow-up period. Moreover, children in the Active group experienced shorter RI duration during the treatment and follow-up phases (p˂0.001 for both). In addition, parents of treated children perceived less severe symptoms and better treatment efficacy during the first and follow-up phases (p˂0.001 for all). The food supplement was well tolerated and there was no adverse event. CONCLUSIONS: The current real-world study demonstrated that Stimunex® gocce supplementation in children with RRI might safely prevent RI episodes and reduce RI duration. These outcomes should be highlighted as obtained during the COVID-19 pandemic era, characterized by a dramatic reduction of RI.

Primary care experience on Stimunex® gocce in children with recurrent respiratory infections: a real-world study during the COVID-19 pandemic era

Background:Respiratory infections (RI) significantly burden society, mainly when there are recurrent respiratory infections (RRI). Thus, there is a need to prevent RI in clinical prac-tice. In this regard, the modulation of the immune system and resolution of the inflamma-tory cascade could represent an ideal way to prevent RI. Stimunex® gocce, a multicomponent food supplement, contains Sambucus nigra extract, β-glucan, Zinc, and Vitamin D3. This study investigated its ability to prevent RRI in children using a real-world setting: the pediatric pri-mary care. Materials and methods:Two hundred and ninety-eight children with RRI were enrolled in the current study. The food supplement was randomly prescribed to 160 children with RRI daily for 4 months (Active group); the remaining 138 children with RRI were treated only with stan-dard therapy for RI (Control group). The number and duration of RI, parental perception of symptom severity and treatment efficacy, use of medications, and school and working absence were evaluated.Results:Children treated with Stimunex® gocce had significantly less RI than the Control group, both concerning upper and lower RI (p<0.001 and 0.003, respectively) during the follow-up period. Moreover, children in the Active group experienced shorter RI duration during the treatment and follow-up phases (p<0.001 for both). In addition, parents of treated children perceived less severe symptoms and better treatment efficacy during the first and follow-up phases (p<0.001 for all). The food supplement was well tolerated and there was no adverse event.Conclusions: The current real-world study demonstrated that Stimunex® gocce supplemen-tation in children with RRI might safely prevent RI episodes and reduce RI duration. These outcomes should be highlighted as obtained during the COVID-19 pandemic era, characterized by a dramatic reduction of RI. (AU)

Use of Streptococcus salivarius K12 to reduce the incidence of pharyngo-tonsillitis and acute otitis media in children: a retrospective analysis in not-recurrent pediatric subjects.

BACKGROUND: Previous trials, performed in subjects affected by recurrent streptococcal pharyngo-tonsillar infection, have shown that the use for 90 days of Streptococcus salivarius K12 (K12), an oral colonizing probiotic producing lantibiotic bacteriocins, reduces the occurrence of streptococcal and viral pharyngitis and acute otitis media (AOM). The aim was to evaluate the role of K12 in reducing the incidence of streptococcal and viral pharyngo-tonsillitis and AOM when administered in two separate trimesters, from October to December and then from April to June, in pediatric subjects with non-recurrent streptococcal infection. METHODS: We retrospectively analyzed the incidence of pharyngo-tonsillitis and AOM in 133 children by comparing the number of episodes occurring between September 1st, 2014 and August 31st, 2015, when no treatment with K12 was given, with the period between September 1st, 2015 and August 31st, 2016, when K12 was administered. RESULTS: Analysis of the findings for the 133 children demonstrated that K12 use decreased the incidence of pharyngo-tonsillitis by about 90% (P<0.001) and the occurrence of AOM by about 70% (P<0.001) and confirms the high safety profile of the strain. CONCLUSIONS: As already demonstrated in subjects with recurrent streptococcal pharyngo-tonsillar infection, K12, if administered for two trimesters out of 12 months, is associated with a reduced incidence of pharyngitis and AOM in pediatric subjects with non-recurrent streptococcal infection.

[ECG for non-competitive sports in childhood: strengths and disputes]. / ECG per l'idoneità all'attività sportiva non agonistica in età pediatrica: punti di forza e controversie.

BACKGROUND: Sport is very important for health promotion and conservation. Active lifestyle and regular exercise reduce cardiovascular disease incidence. The Italian Ministry of Health issued the Law Decree no. 243 (10/18/2014) concerning "guidelines for certification about non-competitive sports" to promote safety in sports. This regulation defines the activities for which a certificate is required, the professional actors involved and the clinical exams to be performed according to the patient's health status. In particular, the Law Decree recommends to perform an electrocardiogram (ECG) "at least once in a lifetime", introducing much greater news into pediatric practice. METHODS: We proposed a survey evaluating frequency of ECG implementation for non-competitive sports and cardiovascular diseases incidence was administered to 7 Ligurian pediatricians. RESULTS: The number of ECG/year for pediatrician increased from 10 ECG/year to 50 ECG/year with an indication of suitability to non-competitive sports. One case of QT prolongation and 2 cases of type 1 Brugada ECG pattern were diagnosed. In addition, 3 patients had an atrial septal defect and 3 children had a ventricular septal defect. Forty-three percent of the pediatricians considered useful performing the ECG. CONCLUSIONS: ECG in children has enhanced the positive effects on the community health. However, it remains to be defined in agreement with scientific societies the age at which to perform ECG, the sports for which ECG is required and the cost-benefit ratio for the National Health System and families.

Plasma homocysteine in patients with retinal vein occlusion.

PURPOSE: To evaluate total plasma homocysteine (HCY) during fasting and post methionine load test (MLT), serum folate, serum vitamin B12, and methylenetetrahydrofolate reductase (MTHFR) mutation in patients with retinal vein occlusion (RVO) and to examine the association between these risk factors and 2 subtypes of RVO: central (CRVO) and branch (BRVO). METHODS: This case-control study included 91 Italian patients presenting a first RVO and 71 healthy subjects, matched by age, without history of thromboembolic diseases, glaucoma, or malignancy. Homocysteine fasting and after MLT, serum folate level, serum vitamin B12 level, and other laboratory tests were assessed. Genetic analysis for the C677T MTHFR mutation was performed. RESULTS: Multivariate logistic regression analysis indicated that hypertension (odds ratio [OR] 2.63; 95% confidence interval [CI] 1.30-5.30; p = 0.007), higher values of fasting HCY (OR 1.16; 95% CI 1.01-1.33; p = 0.03), and low concentrations of vitamin B12 (OR 0.99; 95% CI 0.995-0.999; p = 0.01) were independently correlated with RVO. Moreover, the main determinants for CRVO risk were hypertension (OR 2.46; 95% CI 1.06-5.72; p = 0.04), high values of fasting HCY (OR 1.20; 95% CI 1.02-1.41; p = 0.03), and low concentrations of vitamin B12 (OR 0.99; 95% CI 0.994-0.999; p = 0.008), whereas for BRVO risk only hypertension was significant (OR 2.74; 95% CI 1.24-6.03; p = 0.01). Genotype distribution of the MTHFR C677T mutation did not reveal any significant difference between patients and controls. CONCLUSIONS: These results suggest that elevated fasting HCY levels, low vitamin B12 levels, and hypertension are associated with a risk of RVO, especially for CRVO. Moreover, our data suggest that only hypertension is associated with BRVO risk.

In type 1 diabetes a subset of anti-coxsackievirus B4 antibodies recognize autoantigens and induce apoptosis of pancreatic beta cells.

Type 1 diabetes is characterized by autoimmune destruction of pancreatic beta cells. The role played by autoantibodies directed against beta cells antigens in the pathogenesis of the disease is still unclear. Coxsackievirus B infection has been linked to the onset of type 1 diabetes; however its precise role has not been elucidated yet. To clarify these issues, we screened a random peptide library with sera obtained from 58 patients with recent onset type 1 diabetes, before insulin therapy. We identified an immunodominant peptide recognized by the majority of individual patients'sera, that shares homology with Coxsackievirus B4 VP1 protein and with beta-cell specific autoantigens such as phogrin, phosphofructokinase and voltage-gated L-type calcium channels known to regulate beta cell apoptosis. Antibodies against the peptide affinity-purified from patients' sera, recognized the viral protein and autoantigens; moreover, such antibodies induced apoptosis of the beta cells upon binding the L-type calcium channels expressed on the beta cell surface, suggesting a calcium dependent mechanism. Our results provide evidence that in autoimmune diabetes a subset of anti-Coxsackievirus antibodies are able to induce apoptosis of pancreatic beta cells which is considered the most critical and final step in the development of autoimmune diabetes without which clinical manifestations do not occur.

Epilepsia partialis continua in type 1 diabetes: evolution into epileptic encephalopathy with continuous spike-waves during slow sleep.

Hyperglycemic status may be rarely complicated by Epilepsia partialis continua (EPC) that usually responds to metabolic normalization. Anti-glutamic acid decarboxylase antibodies (GAD-Ab) play a pivotal role in the autoimmune process that leads to clinical onset of type 1 diabetes mellitus (T1DM). GAD-Ab have been recently reported in association with rare forms of refractory epilepsy, with or without association to T1DM. Here we describe a young patient who developed EPC five months after T1DM onset; GAD-Ab were detected in his cerebrospinal fluid with evidence of oligoclonal bands. His epileptic disorder evolved over time into drug-resistant epilepsy with continuous spike-waves during slow sleep and severe behavioral impairment. The role of both metabolic imbalance and GAD autoimmunity is discussed.

Neonatal diabetes mellitus due to pancreatic agenesis and pervasive developmental disorder.

Recent studies suggested a link between type 1 diabetes mellitus and pervasive developmental disorder. Moreover, permanent neonatal diabetes mellitus due to pancreatic agenesis can be associated with neurological deficit involving cerebellar functions, but no association with pervasive developmental disorder has been described so far. Clinical and neuropsychological evaluation of a child with pancreatic agenesis, mental retardation and pervasive developmental disorder is reported.

Beta-cell autoimmunity in pediatric celiac disease: the case for routine screening?

OBJECTIVE: To evaluate the prevalence of beta-cell autoimmunity and the usefulness of a type 1 diabetes screening in patients with celiac disease. RESEARCH DESIGN AND METHODS: We measured GAD antibodies (GADAs), insulinoma-associated protein 2 antigens (IA-2As), and insulin autoantibodies (IAAs) in 188 young Italian patients with celiac disease (66 male [35.1%]). Mean age at celiac disease diagnosis was 5.4 years (0.5-17.1), and mean celiac disease duration was 4.2 years (0-28.8). Celiac disease was diagnosed by jejunal biopsy after positivity for endomysial and tissue transglutaminase antibody was confirmed. RESULTS: GADAs were positive in seven patients (3.7%), and IA-2As were positive in two patients. IAAs were negative in all cases. Metabolic evaluation was normal, and no patients developed diabetes during follow-up. There was no significant association among beta-cell autoimmunity and sex, age, pubertal stage, family history, or coexistence of other autoimmune disorders; compliance to a gluten-free diet was confirmed. CONCLUSIONS: Our results showed a low prevalence of beta-cell autoimmunity and do not support a precocious screening for beta-cell autoimmunity in young celiac disease patients.

Amyand's hernia in a child with permanent neonatal diabetes due to pancreatic agenesis.

Acute or perforated appendicitis within inguinal hernia is rarely encountered and it is known as Amyand's hernia. We report on the first case occurring in a 4-year-old boy affected by permanent neonatal diabetes mellitus due to pancreatic agenesis, an extremely rare condition. The initial suspicion of inguinal hernia was confirmed by ultrasound examination of the right inguinal region which revealed omental layers inside a swollen inguinal canal; this finding and the clinical presentation allowed a prompt and appropriate surgical management. The careful evaluation of this patient and early recognition of this unique presentation of appendicitis allowed trans-hernial appendectomy and immediate herniorrhaphy. Ultrasonography played a pivotal role to reach the correct diagnosis and to start a prompt treatment.

The efficacy of 2002 CDC guidelines in preventing perinatal group B Streptococcal vertical transmission: a prospective study.

OBJECTIVES: The aim of the current study is to evaluate the differences in the rate of perinatal group B streptococcal vertical transmission between women who correctly underwent the CDC 2002 guidelines and women who did not. METHODS: Two study groups: women who correctly underwent the CDC 2002 guidelines (study group 1) and women who did not (study group 2). Intrapartum chemoprophylaxis (IC) was administered to all pregnant women identified as GBS carrier. All newborns received, in the first hour of life, a culture based screening for GBS colonization. RESULTS: One thousand six hundred and sixty nine women were enrolled in the study. The 2002 CDC guidelines were correctly applied in 1273 (76.3%) subjects. There was no early-onset GBS disease. No statistically significant difference in the total number of colonized newborns between study group 1 (4.1%) and study group 2 (3.3%) was found. When the analysis was limited to women with positive GBS screening, a significant difference (P < 0.001) was observed in the number of colonized newborns between mothers who received IC during at least 4 h (group 1; 3.7%) and those who received an IC during less than 4 h (group 1; 12.3%). CONCLUSION: The accurate application of the 2002 CDC guidelines is strongly supported but, to furthermore reduce the risk for GBS colonization and sepsis in the newborns, it appears desirable to identify additional and new prevention strategies.

Epidemiology and clinical course of Burkholderia cepacia complex infections, particularly those caused by different Burkholderia cenocepacia strains, among patients attending an Italian Cystic Fibrosis Center.

In this study, the epidemiology of Burkholderia cepacia complex (Bcc) recovered from the sputum of 75 patients attending the Genoa Cystic Fibrosis (CF) Center at the Gaslini Children's Hospital (Genoa, Italy) was investigated, and the clinical course of the CF patients infected with the different species and genomovars of Bcc was evaluated. All isolates were analyzed for genomovar status by recA gene polymorphism and subsequently random amplified polymorphic DNA fingerprinting. Burkholderia cenocepacia is the predominant species recovered from the CF patients infected with Bcc at the Genoa CF Center. Of the other eight species comprising the Bcc, only a few isolates belonging to B. cepacia genomovar I, Burkholderia stabilis, and Burkholderia pyrrocinia were found. Of the four recA lineages of B. cenocepacia, most patients were infected by epidemic strains belonging to lineages IIIA and IIID, whereas only a few patients harbored IIIB strains. Patient-to-patient spread of Bcc among CF patients was mostly associated with B. cenocepacia, in particular with strains belonging to recA lineages IIIA and IIID. The mortality of CF patients infected with Bcc at the Genoa CF Center was significantly higher than mortality among CF patients not infected with Bcc. All of the deaths were associated with the presence of B. cenocepacia, except the case of a patient infected with B. cepacia genomovar I. Within B. cenocepacia, infection with epidemic strains belonging to lineages IIIA and IIID was associated with higher rates of mortality than was infection with lineage IIIB strains. No significant differences in lung function, body weight, and mortality rate were observed between patients infected with epidemic strains belonging to either B. cenocepacia IIIA or B. cenocepacia IIID.