The safety and efficacy of Streptococcus salivary subspecies K12 in improving recurrent respiratory tract infections in children: a randomized, double-blind, placebo-controlled trial
Recurrent respiratory tract infections in children
Current interventions as of 30/06/2026: Participants were randomised using SPSS to either a low dose of probiotic bacteria (100 million CFP), a high dose of probiotic bacteria (5 billion CFP) or a placebo tablet one time per day (sterile powder, same derivative). The intervention period was 12 weeks, and saliva was taken after the intervention, after 6 weeks of intervention and at the end of the intervention, and the sample inspection was carried out during the 13 weeks of follow-up. At Week 0, Week 3, Week 6, Week 9, Week 12 and Week 16, questionnaires were completed and during the intervention the patients were asked to take the corresponding product every day and record adverse reactions and compliance. During the study, the doctor recorded the incidence of upper respiratory tract infections, including the number of attacks, symptoms, and duration. By analyzing the statistics and analysis of these data, the improvement of the recurrence rate of the upper respiratory tract infection was calculated. In addition, the Canadian Acute Respiratory and Flu Scale (CARIFs) was used to quantify the incidence of upper respiratory infections in participants. _____ Previous interventions as of 29/06/2026: Participants were randomised using SPSS to either a low dose of probiotic bacteria (100 million CFU), a high dose of probiotic bacteria (500 million CFU) or a placebo tablet one time per day (sterile powder, same derivative). The intervention period was 12 weeks, and saliva was taken after the intervention, after 6 weeks of intervention and at the end of the intervention, and the sample inspection was carried out during the 13 weeks of follow-up. At Week 0, Week 3, Week 6, Week 9, Week 12 and Week 16, questionnaires were completed and during the intervention the patients were asked to take the corresponding product every day and record adverse reactions and compliance. During the study, the doctor recorded the incidence of upper respiratory tract infections, including th
1. Consistent with the diagnostic criteria for the clinical and clinical treatment of recurrent respiratory tract infection (2022) 2. Aged 3 to 18 years old 3. During the study (screening to follow-up), no probiotics, probiotics and cogenic milk products were used in this study 4. Agree to sample saliva and other biological samples during this study 5. The guardian of the child is aware of the study and signed the informed consent form
1. In the first month of the group, the children of the same strain were studied 2. Treatments such as antibiotics, disinfectants, antifungal drugs, glucocorticosteroids and other treatments were accepted within 7 days of entering the group 3. Children who need hospitalization for malnutrition 4. Known to be sensitive, intolerant or allergic to any research product (including lactose, milk protein, etc) 5. Use any experimental drugs for the first 3 months of screening and participate in other clinical studies 6. Diagnosis of basic disease, such as above-moderate anemia, ricular disease, chronic diarrhea, stable diseases, congenital cardiovascular malformity, various causes of severe malnutrition, secondary immunodeficiency, kidney disease, cerebral palsy, and long-term immune inhibitors 7. Congenital immunodeficiency diseases (such as the common immunodeficiency disease in China): the X chain does not have hepatitis C, X chain high immunoglobulinemia, eczema, necrosis, or thrombocytopenia immunodeficiency syndrome 8. In the first 3 months of the group, took drugs that affected immune function (immunosuppressant, immunoenhancers, hormones, blood products, Chinese medicine, etc) 9. The researchers judge that there is a discomfort involved in compliance or safety 10. Vaccination or other active vaccines in the first 4 weeks of screening