Beta-(1,3/1,6)-D-glucan from Pleurotus ostreatus in the prevention of recurrent respiratory tract infections: An international, multicentre, open-label, prospective study.

Preschool children are particularly susceptible to recurrent upper and lower respiratory tract infections due to their immune immaturity and other contributing factors. Preventing and/or treating children suffering from recurrent respiratory tract infections (RRTIs) is challenging, and it is important to provide more clinical evidence about the safety and efficacy of natural immunomodulating preparations, including ß-glucans. The aim of the present study was to assess the incidence of respiratory tract infections (RTIs) in children with a history of RRTIs for a period of 6 months (3 months of pleuran supplementation and 3 months of follow-up) compared with the same period from October to March of the previous year prior to enrolment in the study. A total of 1,030 children with a mean age of 3.49 ± 1.91 years from seven countries were included in this study. The total number of RTIs observed during the study period was significantly lower compared to the same period of the previous year (7.07 ± 2.89 vs. 3.87 ± 3.19; p < 0.001). Analysis of each type of RTI revealed significant reductions in the mean number and duration of infections for all RTI subtypes compared to the previous year. This study also confirmed the beneficial safety profile of pleuran supplementation. In conclusion, pleuran supplementation represents an interesting and prospective supplement in preventing respiratory infections and reveals new strategies for supporting immune functions in the paediatric population.

Real-world study in infants fed with an infant formula with two human milk oligosaccharides / Estudio en condiciones reales de lactantes alimentados con una fórmula infantil con dos oligosacáridos de leche humana

INTRODUCTION: human milk oligosaccharides (HMOs) are an important component of human milk supporting the development of a balanced intestinal microbiota and immune protection in breastfed infants. Randomized controlled trials (RCTs) have demonstrated that infant formulas supplemented with the HMOs 2'-fucosyllactose (2'FL) and lacto-N-neotetraose (LNnT) are safe, well-tolerated, and support normal growth. This Real-World Evidence (RWE) study aimed to evaluate growth and tolerance in infants consuming a formula supplemented with 1 g/L of 2'FL and 0.5 g/L of LNnT, and included a mixed-feeding group never studied before in RCTs. Participants and methods: this open-label, prospective study was conducted at six centers in Spain, and included healthy, exclusively breastfed infants (BF group), an exclusively formula-fed group (FF) who received a milk-based formula with 2' FL and LNnT, and a group mixed fed with both formula and human milk (MF), for 8 weeks. Co-primary outcomes were growth (anthropometry) and gastrointestinal tolerance (Infant Gastrointestinal Symptom Questionnaire, IGSQ). Secondary outcomes included formula satisfaction and adverse events (AEs). RESULTS: 159 infants completed the study (66 FF, 48 MF, and 45 BF). Mean z-scores for growth were similar between all groups and within ± 0.5 of WHO medians at week 8. Composite IGSQ scores demonstrated low GI distress in all groups, with no significant group differences at baseline, week 4, or week 8. Incidence of AEs was low overall, and comparable across groups. CONCLUSIONS: in this RWE study examining a HMO-supplemented infant formula, growth and tolerance outcomes were similar to RCT findings, supporting the effectiveness of this early feeding option

INTRODUCCIÓN: los oligosacáridos de la leche materna (HMO) contribuyen a desarrollar la inmunoprotección y la microbiota intestinal. Los ensayos aleatorizados (RCT) han demostrado que las fórmulas enriquecidas con 2'fucosilactosa (2'FL) y lacto-N-neotetraosa (LNnT) son seguras, bien toleradas y favorecen el crecimiento. El objetivo de este estudio ha sido valorar el crecimiento, la seguridad y la tolerancia digestiva en lactantes alimentados con una fórmula enriquecida con 1 g/L de 2'FL y 0,5 g/L de LNnT, con datos de la vida real (RWE), incluyendo un grupo de alimentación mixta no estudiado antes en los RCT. Participantes y métodos: estudio prospectivo abierto en seis hospitales españoles que incluyó lactantes sanos alimentados con leche materna (BF), con fórmula enriquecida en 2'FL y LNnT (FF) o con mezcla de ambas (MF), durante ocho semanas. Se valoraron el crecimiento (antropometría), la tolerancia gastrointestinal (cuestionario IGSQ) y los acontecimientos adversos. RESULTADOS: 159 lactantes completaron el estudio (66, 48 y 45, en los grupos FF, MF y BF, respectivamente). Las puntuaciones Z antropométricas a la semana 8 fueron similares entre los grupos y se hallaron dentro del rango de ± 0,5 de la normalidad. Las puntuaciones IGSQ compuestas mostraron un bajo malestar digestivo, sin diferencias significativas entre los grupos, al inicio y en las semanas 4 y 8. La incidencia de eventos adversos fue baja y comparable entre los grupos. CONCLUSIONES: en este estudio RWE que evaluó una fórmula para lactantes enriquecida en HMO, los resultados sobre el crecimiento, la tolerancia y la seguridad fueron similares a los obtenidos en los RCT, respaldando su eficacia como alimentación temprana opcional

Real-world study in infants fed with an infant formula with two human milk oligosaccharides.

Introduction: Introduction: human milk oligosaccharides (HMOs) are an important component of human milk supporting the development of a balanced intestinal microbiota and immune protection in breastfed infants. Randomized controlled trials (RCTs) have demonstrated that infant formulas supplemented with the HMOs 2'-fucosyllactose (2'FL) and lacto-N-neotetraose (LNnT) are safe, well-tolerated, and support normal growth. This Real-World Evidence (RWE) study aimed to evaluate growth and tolerance in infants consuming a formula supplemented with 1 g/L of 2'FL and 0.5 g/L of LNnT, and included a mixed-feeding group never studied before in RCTs. Participants and methods: this open-label, prospective study was conducted at six centers in Spain, and included healthy, exclusively breastfed infants (BF group), an exclusively formula-fed group (FF) who received a milk-based formula with 2' FL and LNnT, and a group mixed fed with both formula and human milk (MF), for 8 weeks. Co-primary outcomes were growth (anthropometry) and gastrointestinal tolerance (Infant Gastrointestinal Symptom Questionnaire, IGSQ). Secondary outcomes included formula satisfaction and adverse events (AEs). Results: 159 infants completed the study (66 FF, 48 MF, and 45 BF). Mean z-scores for growth were similar between all groups and within ± 0.5 of WHO medians at week 8. Composite IGSQ scores demonstrated low GI distress in all groups, with no significant group differences at baseline, week 4, or week 8. Incidence of AEs was low overall, and comparable across groups. Conclusions: in this RWE study examining a HMO-supplemented infant formula, growth and tolerance outcomes were similar to RCT findings, supporting the effectiveness of this early feeding option.

Introducción: Introducción: los oligosacáridos de la leche materna (HMO) contribuyen a desarrollar la inmunoprotección y la microbiota intestinal. Los ensayos aleatorizados (RCT) han demostrado que las fórmulas enriquecidas con 2'fucosilactosa (2'FL) y lacto-N-neotetraosa (LNnT) son seguras, bien toleradas y favorecen el crecimiento. El objetivo de este estudio ha sido valorar el crecimiento, la seguridad y la tolerancia digestiva en lactantes alimentados con una fórmula enriquecida con 1 g/L de 2'FL y 0,5 g/L de LNnT, con datos de la vida real (RWE), incluyendo un grupo de alimentación mixta no estudiado antes en los RCT. Participantes y métodos: estudio prospectivo abierto en seis hospitales españoles que incluyó lactantes sanos alimentados con leche materna (BF), con fórmula enriquecida en 2'FL y LNnT (FF) o con mezcla de ambas (MF), durante ocho semanas. Se valoraron el crecimiento (antropometría), la tolerancia gastrointestinal (cuestionario IGSQ) y los acontecimientos adversos. Resultados: 159 lactantes completaron el estudio (66, 48 y 45, en los grupos FF, MF y BF, respectivamente). Las puntuaciones Z antropométricas a la semana 8 fueron similares entre los grupos y se hallaron dentro del rango de ± 0,5 de la normalidad. Las puntuaciones IGSQ compuestas mostraron un bajo malestar digestivo, sin diferencias significativas entre los grupos, al inicio y en las semanas 4 y 8. La incidencia de eventos adversos fue baja y comparable entre los grupos. Conclusiones: en este estudio RWE que evaluó una fórmula para lactantes enriquecida en HMO, los resultados sobre el crecimiento, la tolerancia y la seguridad fueron similares a los obtenidos en los RCT, respaldando su eficacia como alimentación temprana opcional.

Evaluación del dolor en niños de 2, 4 y 6 meses tras la aplicación de métodos de analgesia no farmacológica durante la vacunación / Evaluation of pain in children of 2, 4 and 6 months after the application of non-pharmacological analgesia methods during vaccination

Introducción: Los niños pequeños tienen una percepción del dolor igual o incluso mayor que los adultos, lo que puede tener consecuencias a corto y largo plazo. Se han descrito intervenciones no farmacológicas para aliviar el dolor en los niños durante el acto de la vacunación. El objetivo de este estudio es valorar 3de estas intervenciones para reducir el dolor asociado a la vacunación: succión no nutritiva (SNN), amamantamiento (LM) y solución de glucosa al 50% (SG50). Material y métodos: Estudio prospectivo, no aleatorizado, de cohortes en niños de 2, 4 y 6 meses que reciben 2, 3 y 1 vacuna, respectivamente, según calendario vacunal sistemático. Se realizaron 3 intervenciones: SNN, LM y ofrecer 2ml de suero glucosado al 50% con SNN. La medición del dolor se efectuó con la escala LLANTO y con el tiempo de llanto. Resultados: Se incluyó a 387 niños. La media de la escala LLANTO a los 2 y 6 meses era significativamente menor en los niños amamantados que en los niños con SNN (p = 0,025 y p < 0,001, respectivamente) y en los que recibían SG50 (p = 0,025 y p = 0,001), sin significación estadística a los 4 meses (p = 0,21 y p = 0,27). No hubo diferencias significativas entre los niños con SNN y SG50 a los 2, 4 y 6 meses (p = 0,66; p = 0,93 y p = 0,45, respectivamente). El tiempo de llanto fue significativamente menor a los 6 meses en los niños amamantados que en los que recibieron SNN o SG50 (p = 0,013 y p = 0,017). Ningún niño amamantado (n = 129) presentó efectos secundarios. Conclusiones: En los niños nacidos a término, con peso adecuado a su edad gestacional, el amamantamiento disminuye el dolor cuando se administran 1 y 2 vacunas; cuando se administran 3 vacunas, la disminución es mínima. La administración de SG50 no tiene efecto analgésico adicional respecto a la vacunación de los niños en brazos de sus padres con SNN. La administración de LM durante la vacunación no tiene ningún efecto secundario

Introduction: Young children perceive pain as much, or even more than adults, and the pain may have short- and long-term consequences. The literature describes the use of non-pharmacological interventions to alleviate pain during vaccination. The aim of this study was to assess 3such interventions for analgesia during vaccination: non-nutritive sucking (NNS), breastfeeding (BF), and administration of a 50% dextrose solution (D50W). Materials and methods: A prospective, non-randomised cohort study was carried out on infants aged 2, 4 and 6 months that received 1, 2, or 3 vaccines, respectively, according to the routine immunisation schedule. There were 3 treatments: NNS, BF, and 2 mL of D50W combined with NNS. Pain was assessed using the LLANTO scale, and the duration of crying. Results: The study included 387 infants. The mean scores in the LLANTO scale at ages 2 and 6 months were significantly lower in breastfed infants compared to infants managed with NNS (P = .025 and P < .001, respectively), or infants given D50W (P = .025 and P = .001), and the difference was not statistically significant at age 4 months (P = .21 and P = .27). There were no significant differences between infants managed with NNS and D50W at 2, 4, and 6 months (P = .66, P = .93 and P = .45, respectively). The duration of crying was significantly lower at age 6 months in breastfeed infants compared to infants managed with NNS or D50W (P = .013 and P = .017). No breastfed child (n = 129) experienced side effects. Conclusions: In infants born to term with adequate weight for gestational age, breastfeeding reduces pain on the administration of 1 or 2 vaccines. When 3 vaccines are given, the reduction is minimal. Administration of D50W does not have any additional analgesic effect in infants compared to being held by a parent combined with NNS during vaccination. BF during vaccination is not associated with any side effects

[Evaluation of pain in children of 2, 4 and 6 months after the application of non-pharmacological analgesia methods during vaccination]. / Evaluación del dolor en niños de 2, 4 y 6 meses tras la aplicación de métodos de analgesia no farmacológica durante la vacunación.

INTRODUCTION: Young children perceive pain as much, or even more than adults, and the pain may have short- and long-term consequences. The literature describes the use of non-pharmacological interventions to alleviate pain during vaccination. The aim of this study was to assess 3such interventions for analgesia during vaccination: non-nutritive sucking (NNS), breastfeeding (BF), and administration of a 50% dextrose solution (D50W). MATERIALS AND METHODS: A prospective, non-randomised cohort study was carried out on infants aged 2, 4 and 6 months that received 1, 2, or 3 vaccines, respectively, according to the routine immunisation schedule. There were 3treatments: NNS, BF, and 2mL of D50W combined with NNS. Pain was assessed using the LLANTO scale, and the duration of crying. RESULTS: The study included 387 infants. The mean scores in the LLANTO scale at ages 2 and 6 months were significantly lower in breastfed infants compared to infants managed with NNS (P=.025 and P<.001, respectively), or infants given D50W (P=.025 and P=.001), and the difference was not statistically significant at age 4 months (P=.21 and P=.27). There were no significant differences between infants managed with NNS and D50W at 2, 4, and 6 months (P=.66, P=.93 and P=.45, respectively). The duration of crying was significantly lower at age 6 months in breastfeed infants compared to infants managed with NNS or D50W (P=.013 and P=.017). No breastfed child (n=129) experienced side effects. CONCLUSIONS: In infants born to term with adequate weight for gestational age, breastfeeding reduces pain on the administration of 1 or 2 vaccines. When 3 vaccines are given, the reduction is minimal. Administration of D50W does not have any additional analgesic effect in infants compared to being held by a parent combined with NNS during vaccination. BF during vaccination is not associated with any side effects.