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The study aims to investigate the effect of the level of probiotic K12 content on enhancing children's immunity and reducing the frequency of their occurrence of diseases such as pharyngitis, tonsillitis, and rhinitis

The safety and efficacy of Streptococcus salivary subspecies K12 in improving recurrent respiratory tract infections in children: a randomized, double-blind, placebo-controlled trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN33436648
Enrollment
180
Registered
2026-05-12
Start date
2026-03-31
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent respiratory tract infections in children Respiratory

Interventions

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 p

Sponsors

Baoxing Center for Disease Control and Prevention
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 18 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Upper respiratory tract infections measured using the number of episodes, symptom manifestations, duration and the Canadian Acute Respiratory Illness and Flu Scale (CARIFs), at Week 0, Week 3, Week 6, Week 9, Week 12 and Week 16

Countries

China

Contacts

Public ContactKe Chen
kechen@uestc.edu.cn+86 (0)13981782973

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026