Oropharyngeal Probiotic ENT-K12 as an Effective Dietary Intervention for Children With Recurrent Respiratory Tract Infections During Cold Season.

Recurrent respiratory tract infections (RRTi) cause a high burden of disease and lead to negative impact on quality of life, frequent school/work absenteeism, and doctor visits, which remain a great challenge to pediatricians because RRTi can increase the risk of various complications including antibiotic overuse and resistance, which is one of the biggest threats to global health, and there is no confirmed effective treatment. In this study, we aimed to assess the clinical efficacy and safety of oropharyngeal probiotic ENT-K12 as a dietary intervention or a complementary treatment along with standard medical treatment during acute respiratory infections among children with RRTi during cold season. The results of this study show that when comparing to practicing of standard medical treatment only, the complementary intake of oropharyngeal probiotic ENT-K12 can effectively reduce episodes of both acute and RRTi in school children, shorten the course of respiratory symptoms onset, reduce the use of antibiotics and antiviral drugs, and reduce the absence days from both children's school and parents' work. Using oropharyngeal probiotics as a complementary dietary intervention to stabilize oropharyngeal microflora, specifically inhibiting respiratory pathogens and enhancing host immunity, could possibly be a promising approach to reduce RRTi burden and combating antibiotic resistance in long term, more clinical studies will be needed to further confirm the clinical practicing guide to ensure its clinical benefit. A total of 100 susceptible children with RRTi aged 3-10 years, living in Wuhan, China, were selected. They were randomized to the probiotic group and control group at the beginning of the trial during the cold season. Fifty children in the probiotic group took oropharyngeal probiotic ENT-K12 for 30 days, along with standard medical treatment when there was an onset of respiratory symptoms and medical treatment was needed, and fifty children in the control group did not take oropharyngeal probiotics but only had standard medical treatment when there was an onset of respiratory symptoms and medical treatment was needed. Patients were followed up for 30 days during the cold season. The primary objective of this study is to assess the complementary dietary interventional efficacy of oropharyngeal probiotic ENT-K12 on episodes of respiratory tract infections during the cold season, and the secondary objective is to assess the interventional efficacy of oropharyngeal probiotic on days of respiratory symptoms onset, using antiviral drugs, antibiotics, and antipyretics, days of children absent from school, and days of parents absent from work, as well as to confirm tolerability and safety judged by adverse event reporting. There were 47 children, 22 male and 25 female children, with an average age of 5.71 years (SD = 1.99) in the probiotic group finishing the study, and 50 children, 32 male and 18 female children, in the control group with an average age of 6.12 years (SD = 1.98) finishing the study. During the 30-day period of oropharyngeal probiotic intake, children in the probiotic group totally had 7 episodes of upper respiratory tract infections, while children in the control group totally had 17 episodes of upper respiratory tract infections, indicating that the incidence of upper respiratory tract infection in the probiotic group (14.89%) was significantly lower than that in the control group (34.00%) during the intervention period. The days of using antibiotics and antiviral drugs in the probiotic group were significantly lower than that in the control group, and the course of respiratory symptoms onset was shorter and more moderate in the probiotic group than that in the control group; in addition, compared with the control group, both the days of children absent from school and parents' absence from work in the probiotic group were significantly lower. Children treated with oropharyngeal probiotic ENT-K12 had excellent tolerability with no side effects reported, hence confirmed safety of applying oropharyngeal probiotic ENT-K12 as a prophylactic use or an effective dietary intervention along with standard medication during respiratory infections onset. Intake of oropharyngeal probiotic ENT-K12 as a dietary intervention can effectively reduce episodes of upper respiratory tract infections in school children with RRTi during high peak season, reduce the days of using antibiotics and antiviral drugs, and reduce children's sick leave days, parents' absence days from work, and shorten the course of respiratory infections; the safety of oropharyngeal probiotic ENT-K12 has been confirmed with no side effects reported, excellent tolerability, and easy acceptance. Notably, this study opens up a new research idea in the field of microbe promoting human health by supplying direct proof to support its efficiency and safety.

Guo H ，Xiang X ，Lin X ，Wang Q ，Qin S ，Lu X ，Xu J ，Fang Y ，Liu Y ，Cui J ，Li Z ... -  《Frontiers in Nutrition》

Oropharyngeal Probiotic ENT-K12 Prevents Respiratory Tract Infections Among Frontline Medical Staff Fighting Against COVID-19: A Pilot Study.

Healthcare workers at the frontline are facing a substantial risk of respiratory tract infection during the COVID-19 outbreak due to an extremely stressful work schedule and public health event. A well-established first-line defense on oropharyngeal microbiome could be a promising strategy to protect individuals from respiratory tract infections including COVID-19. The most thoroughly studied oropharyngeal probiotic product which creates a stable upper respiratory tract microbiota capable of preventing upper respiratory tract infections was chosen to evaluate the safety and efficacy on reducing episodes of upper respiratory tract infections for COVID-19 healthcare workers. To our knowledge to date, this is the very first study describing the beneficial effects of oropharyngeal probiotic been administered by healthcare workers during the COVID-19 pandemic. In this randomized controlled trial, we provided the probiotics to frontline medical staff who work in the hospitals in Wuhan and had been in close contact with hospitalized COVID-19 patients for prophylactic use on a daily basis. Our finding suggests that oropharyngeal probiotic administration significantly reduced the incidence of respiratory tract infections by 64.8%, reduced the time experiencing respiratory tract infections and oral ulcer symptoms by 78%, shortened the days absent from work by 95.5%, and reduced the time under medication where there is no record of antibiotic and anti-viral drug intake in the probiotic group. Furthermore, medical staff treated with Bactoblis experienced sustained protection from respiratory tract infections since the 10th day of oropharyngeal probiotic administration resulting in an extremely low incidence rate of respiratory tract infections.

Wang Q ，Lin X ，Xiang X ，Liu W ，Fang Y ，Chen H ，Tang F ，Guo H ，Chen D ，Hu X ，Wu Q ，Zhu B ，Xia J ... -  《Frontiers in Bioengineering and Biotechnology》

Pilot study to explore the prophylactic efficacy of oral probiotic Streptococcus salivarius K12 in preventing recurrent pharyngo-tonsillar episodes in pediatric patients.

Marini G ，Sitzia E ，Panatta ML ，De Vincentiis GC ... -  《International Journal of General Medicine》

Exploring association between gastrointestinal heat retention syndrome and recurrent respiratory tract infections in children: a prospective cohort study.

Dong F ，Yu H ，Ma J ，Wu L ，Liu T ，Lv G ，Zhen J ，Li X ，Lewith G ，Gu X ... -  《BMC Complementary and Alternative Medicine》

Use of Streptococcus salivarius K12 in the prevention of streptococcal and viral pharyngotonsillitis in children.

Di Pierro F ，Colombo M ，Zanvit A ，Risso P ，Rottoli AS ... -  《-》