Impact of individual molecular components in determining primary sensitization to latex.

Allergy to natural rubber latex emerged as one of the main allergies at the beginning among some professional groups and the general population. Sensitization and development of latex allergy have been attributed to exposure to products containing residual latex proteins. The prevailing cross-reactivity of latex proteins with other food allergens is of great concern. Numerous purified allergens are currently available, which greatly help in patient management, thus determining their specific profile. We conducted a multicenter study to investigate changes, from the ROC analysis, in the characteristics of patients with latex allergy by measuring its major protein components. Sensitization to latex proteins is crucial because it highlights the cross reactivity to inhalants (pollen) and food (fruit). It is very essential in an accurate and specific clinical setting.

A polycentric, randomized, double blind, parallel-group, placebo-controlled study on Lertal®, a multicomponent nutraceutical, as add-on treatment in children with allergic rhinoconjunctivitis: phase I during active treatment.

Allergic rhinoconjunctivitis (AR) treatment is usually pharmacological in children, but medications are merely symptomatic, may not be completely effective, and may have relevant side effects. Thus, doctors and parents look at complementary medicine, including nutraceuticals. Lertal®, an oral nutraceutical, contains extract of Perilla, quercetin, and Vitamin D3 It has been reported that adults with AR diminished allergic symptoms and medication use during Lertal® therapy. Therefore, the current polycentric, randomized, double blind, parallel-group, placebo-controlled study aimed to evaluate the efficacy and safety of Lertal® as an add-on treatment in children with AR. In this study, 146 children (94 males and 52 females, mean age 9.1±1.88) were randomly assigned to Lertal® + standard treatment or Placebo + standard treatment and were visited at baseline (W0), and after 2 (W2) and 4 weeks (W4). Standard treatment consisted of continuous antihistaminic schedule. The primary endpoint was the Total Symptom Score (TSS - last 12 hours) change from the baseline to the end of the 4-week treatment. Both groups significantly (p less 0.0001 for both) reduced TSS (last 12 hours) after 4 weeks (% change: - 63.6% in Lertal®-group and - 60.7% in Placebo-group; p= n.s. intergroup analysis). Notably, 24 children had symptom worsening between W2 and W4: 8 in the Lertal®-group and 16 in the Placebo-group, with significant intergroup difference (p less than 0.05). All of them were poly-allergic subjects exposed to multiple allergens. There was no relevant adverse event. The present study documented that Lertal®, as add-on treatment, was able to significantly prevent the occurrence of clinical worsening and was safe in AR poly-allergic children.

Pidotimod may prevent recurrent respiratory infections in children.

AIM: Recurrent respiratory infections (RRI) constitute a social problem for both the pharmaco-economic impact and the burden for the family. Pidotimod is a synthetic immunostimulant. The aim of this study was to evaluate the effects of pidotimod on RRI prevention in children. METHODS: Globally, 100 children (49 males, mean age 4.7 ± 1.2 years) with RRI were enrolled in the study. At baseline, children were randomly assigned to the treatment with pidotimod 400 mg/die or not for two months. Children were visited at baseline, after 30 (T1) and 60 (T2) days, and at follow-up (120 days; T3). Number of children with upper and lower airways symptoms, medications use, school attendance, and paediatric visits for RRI were evaluated. RESULTS: Pidotimod treatment was able of significantly reducing the number of children with upper and lower airways symptoms, and medications use, increasing school attendance, and reducing pediatric visits for RRI. CONCLUSION: This study provided the evidence that pidotimod may be able of preventing RRI in children.

Evaluation of the effects of a probiotic supplementation with respect to placebo on intestinal microflora and secretory IgA production, during antibiotic therapy, in children affected by recurrent airway infections and skin symptoms.

Antibiotic therapy, especially in pediatric patients, is often associated with significant modifications of the gut microflora, which can lead to intestinal dysbiosis and influence intestinal physiology and immune system functionality. Herein we report the results from a double blind controlled clinical trial in 77 pediatric patients affected by recurrent airway infections, receiving antibiotic therapy with amoxicillin and clavulanic acid. A group was treated with an oral probiotic preparation composed of Lactobacillus paracasei ssp.paracasei CRL-431, Bifidobacterium BB-12, Streptococcus thermophilus TH-4 and a fructooligosaccharide (FOS) during and after antibiotic therapy for seven days, while the other group received placebo. The study revealed a reduction in the Clostridia population, with a contemporary increase in Bifidobacteria and Lactobacilli in fecal samples in the probiotic group and an increase in the Enterobacteria population in the placebo group. Moreover, there was a decreasing trend in secretory IgA production in the probiotic group. Some relevant, but not statistically significant probiotic supplementation effects were identified.

Serum IL-9 levels and sublingual immunotherapy: preliminary report.

Th9 is a new T cell subset characterized by IL-9 production. It has been reported that serum IL-9 levels are related with symptom severity in patients with allergic rhinitis (AR). This study is aimed at investigating whether serum IL-9 may be modulated by sublingual immunotherapy (SLIT) in patients with persistent AR due to Parietaria allergy. Twenty-one AR patients (9 males, median age 41 years) successfully treated with SLIT and 52 AR patients (25 males, median age 34 years) treated only with drugs were evaluated during the pollen season. Serum IL-9 was dosed in all patients. SLIT-treated patients showed significantly lower serum IL-9 levels than untreated AR patients (p <0.0001). In conclusion, this preliminary study shows that a single pre-seasonal SLIT course might modulate serum IL-9.

Immunoglobulin production pattern is allergen-specific in polysensitized patients.

Allergic rhinitis (AR) is characterized by Th2 polarized immune response, such as increased IL-4 and reduced IFN-gamma production, and by a functional defect of T regulatory cells. This impaired immune response profile influences the pattern of immunoglobulin production in allergic patients. Therefore, the aim of this study is firstly to investigate the allergen-specific IgE, IgG, IgG4, and IgA serum level pattern in polysensitized AR patients with the same skin prick test positivity to some pollen allergens. Secondly, this study aims at relating immunoglobulin (Ig) values with some clinical and immunological parameters. Eighty polysensitized patients with AR were enrolled. Serum allergen-specific IgE, IgG, IgG4, and IgA for mites, Parietaria, grasses, and birch, TGF-beta and sHLA-G were determined by the ELISA method. Allergic symptoms and drugs use were also assessed. Allergen-specific IgE, IgG, IgG4, and IgA serum levels were significantly different for each tested allergen (p=0.0001). There was a significant correlation between IgE levels and allergy severity, whereas IgA had an antagonistic behaviour, considering mite-specific immunoglobulins. In conclusion, the present study provides the first evidence that immunoglobulin production pattern depends on the specificity of the allergenic response.

Sublingual immunotherapy affects specific antibody and TGF-beta serum levels in patients with allergic rhinitis.

Allergic rhinitis (AR) is characterized by Th2 polarized immune response, such as increased IL-4 and reduced IFN-gamma production. Sublingual allergen-specific immunotherapy (SLIT) induces several immunological changes, most of which are still little known. The aim of this study is firstly to investigate the changes of allergen-specific IgE, IgG, IgG4, and IgA serum levels after SLIT. Secondly, this study aims at relating immunoglobulin (Ig) values with some Th1-, Th2-, and Treg-dependent cytokines. Twenty-three patients with pollen-induced AR were enrolled, and they assumed two pre-seasonal SLIT courses for 2 years. Serum allergen-specific IgE, IgG, IgG4 and IgA levels were determined by ELISA method at baseline and after each SLIT course. Serum IL-4, IFN-gamma, IL-10, and TGF-beta levels were also assessed. Allergen-specific IgE, IgG, IgG4, and IgA serum levels significantly increased after SLIT. Serum TGF-beta significantly increased after SLIT. There was a significant correlation between IgA and TGF-beta, both after the first and the second SLIT course. In conclusion, the present study provides the first evidence that pollen SLIT significantly affects Ig production, mainly concerning IgA; and IgA increase is related with TGF-beta production. Moreover, this is the first study that measured Ig classes by using a quantitative method.

Immunoactivation by pidotimod in children with recurrent respiratory infections.

The therapeutic activity and safety of pidotimod ((R)-3-[(S)-(5-oxo-2-pyrrolidinyl) carbonyl]-thiazolidine-4-carboxylic acid, PGT/1A, CAS 121808-62-6), a new synthetic "biological response modifier", were examined in a double-blind, placebo-controlled, multicentre trial in 101 children, including 53 boys and 48 girls aged 2-13 years (mean +/- SD: 4.7 +/- 2.1 years) with a history of recurrent respiratory infections (RRI). Pidotimod (400 mg/day) or placebo were administered orally for 60 consecutive days, followed by a further 60-day follow-up period. The trial was completed by 89.1% of patients. The results indicate that pidotimod has a beneficial effect in children with recurrent respiratory infections: the percentage of patients presenting symptoms affecting the upper and lower airways was significantly lower after treatment with the active drug than after treatment with placebo. Relevant side effects were not reported during the trial. An evaluation of the expression of CD25 (after in vitro stimulation of circulating mononuclear cells with PHA) before and after treatment with the two products revealed a significant increase in CD25+ cells in the group treated with pidotimod but not in the group treated with placebo.