Recurrent Respiratory Infections in Children
Conditions
Interventions
Intervention group:In addition to acute phase control, prophylaxis with bacterial lysates or other immunomodulatory drugs is effective. Some RRTIs children mainly infected with specific tissues and or
Dosage and time of probiotics: once a day, 1 pack each time (containing animal bifidobacterium lactobacillus subspecies + Lactobacillus plantarum), the course of treatment starts from the day of drug
Control group:Receive conventional treatment such as anti-infection and symptomatic treatment, and do not use probiotics in the treatment process
At the same time, placebo (same appearance and taste as probiotics but no beneficial bacteriogenic ingredients) was administered as in the RRTIs intervention group.
Sponsors
Chengdu Women and Children‘s Central Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 14 Years
Inclusion criteria
Inclusion criteria: 1: Meet the diagnostic criteria of Clinical Diagnosis and Treatment Pathways for recurrent Respiratory Infections in Children (2022 edition) formulated by Respiratory Group and Immunology Group of Pediatrics Society of Chinese Medical Association 2: Age: 0~14 years old, gender is not limited 3: Willing to stop taking other probiotics during the trial 4: Consent to the collection of biological samples such as stool and blood during the study period 5:The guardian of the child is aware of this study and signs the informed consent.
Exclusion criteria
Exclusion criteria: 1: Children born before 37 weeks of pregnancy 2: Birth weight less than 2500g, or more than 4000g 3: Children who used probiotics of the same strain as in this study within 1 month before enrollment 4: Patients who had received antibiotics, disinfectants, antifungal drugs, glucocorticoids and other treatments within 7 days before enrollment;5: Malnourished children requiring hospital treatment 5: Malnourished children requiring hospital treatment 6: Children known to be allergic to the probiotic product ingredients used in this study 7: Use of any investigational drug within 3 months prior to screening and participate in other clinical studies 8: Patients with diagnosed underlying diseases, such as moderate or above anemia, rickets, chronic diarrhea and other wasting diseases, congenital cardiovascular malformation, severe malnutrition caused by various causes, secondary immune deficiency, kidney disease, cerebral palsy, and long-term immunosuppressive treatment 9: There are congenital immune deficiency diseases (such as China's common immune deficiency diseases: X-linked agammaglobulinemia, X-linked hyperimmunoglobulinemia, Eczema, platelet with immune deficiency syndrome, etc.) 10: Taking drugs that affect immune function (immunosuppressants, immune enhancers, hormones, blood products, traditional Chinese medicine preparations, etc.) in the 3 months before enrollment 11: Those who were considered by the researchers to have affected efficacy evaluation or poor compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of respiratory infections; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum levels of common immunoglobulins (IgA, IgG, IgM) and complement C3/C4 were determined;Family quality score;Gut microbiota analysis; | — |
Countries
China
Contacts
Public ContactChen Ke
Chengdu Women and Children‘s Central Hospital
Outcome results
None listed