OBJECTIVES: Recurrent respiratory tract infections (RRTIs) represent a very important problem in daily clinical practice because of their significant contribution to morbidity in children. Several natural nutritional supplements have been used in the prevention of RRTIs, but the clinical efficacy of only a few preparations is supported by scientific evidence. MATERIALS AND METHODS: In a double-blind, placebo-controlled, randomised, multicentre study, we have observed a group of 175 children (aged 5.65 ± 2.39 years) with more than 5 respiratory infections that occurred during the 12 months prior to the beginning of the study. Children were randomised into an active group, treated with Imunoglukan P4H® syrup (with pleuran-β-glucan from Pleurotus ostreatus and vitamin C), or a placebo group (vitamin C only). During the 3 visits, within a 12-month period, questionnaires were completed, and blood samples were examined for immune parameters. RESULTS: In the active group, 36% of the children did not suffer from any respiratory infections throughout the treatment, compared to 21% in the placebo group (p<0.05). Imunoglukan P4H® also significantly decreased the frequency of flu and flu-like disease and the number of lower respiratory tract infections. Imunoglukan P4H® treatment resulted in a statistically significant modulation of humoral and cellular immunity. CONCLUSIONS: Results from this study demonstrate that Imunoglukan P4H® is effective in the prevention of RRTIs in children. Furthermore, our results also revealed complex immunomodulatory activity of this product. This is the first double-blind, placebo-controlled study in children with RRTIs that has addressed the preventive effects of pleuran on morbidity caused by respiratory infections.
RCT Entities:
OBJECTIVES: Recurrent respiratory tract infections (RRTIs) represent a very important problem in daily clinical practice because of their significant contribution to morbidity in children. Several natural nutritional supplements have been used in the prevention of RRTIs, but the clinical efficacy of only a few preparations is supported by scientific evidence. MATERIALS AND METHODS: In a double-blind, placebo-controlled, randomised, multicentre study, we have observed a group of 175 children (aged 5.65 ± 2.39 years) with more than 5 respiratory infections that occurred during the 12 months prior to the beginning of the study. Children were randomised into an active group, treated with Imunoglukan P4H® syrup (with pleuran-β-glucan from Pleurotus ostreatus and vitamin C), or a placebo group (vitamin C only). During the 3 visits, within a 12-month period, questionnaires were completed, and blood samples were examined for immune parameters. RESULTS: In the active group, 36% of the children did not suffer from any respiratory infections throughout the treatment, compared to 21% in the placebo group (p<0.05). Imunoglukan P4H® also significantly decreased the frequency of flu and flu-like disease and the number of lower respiratory tract infections. Imunoglukan P4H® treatment resulted in a statistically significant modulation of humoral and cellular immunity. CONCLUSIONS: Results from this study demonstrate that Imunoglukan P4H® is effective in the prevention of RRTIs in children. Furthermore, our results also revealed complex immunomodulatory activity of this product. This is the first double-blind, placebo-controlled study in children with RRTIs that has addressed the preventive effects of pleuran on morbidity caused by respiratory infections.
Authors: Alfonso Maria Varricchio; Michele Capasso; Antonio Della Volpe; Luigi Malafronte; Nicola Mansi; Attilio Varricchio; Giorgio Ciprandi Journal: Ital J Pediatr Date: 2014-11-23 Impact factor: 2.638