Allergic disease in children Other
Conditions
Interventions
A public health epidemic professional who is not directly involved in the execution of the study will use the RAND function in Excel to generate random numbers. Children who meet the inclusion criteri
Sponsors
Baoxing County Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy infants born at 37 to 42 weeks of gestation were artificially fed and had a birth weight greater than or equal to 2500 and less than 4000 g, without sex restriction 2. The infant's mother has no diagnosed metabolic diseases such as diabetes, hepatitis B, HIV and other infectious diseases 3. Three age groups were included: 0~6 months old, 7~12 months old and 13~36 months old 4. The child's parent or primary guardian consents to the collection of faecal samples during the study period; 5. No clinically diagnosed allergic diseases at the time of enrollment (including but not limited to eczema, asthma, allergic proctocolitis, allergic rhinitis, hay fever, etc) 6. Register in the child care department of the local maternal and child health hospital and receive regular physical examinations and feeding advice and guidance from the child health doctor 7. The family or primary guardian commits not to add additional probiotic products (including formula containing probiotics) to the infant during the intervention period 8. The guardian of enrolled subjects agrees to participate in the intervention study and signs a written informed consent, and can understand and fill in the infant diary and other forms as required
Exclusion criteria
Exclusion criteria: 1. The infant has a history of birth asphyxia or NICU hospitalization 2. The child has a birth defect or congenital abnormality 3. The mothers of infants and young children have pregnancy-induced hypertension syndrome, eclampsia and preeclampsia, gestational diabetes, gestational cholestasis and other obstetric risk factors, and history of alcoholism and drug abuse 4. The infants had used antibiotics within 2 weeks before enrollment 5. Diseases that definitely affect the growth and development of infants (such as pneumonia, severe diarrhea, severe constipation, severe milk protein allergy, malnutrition, gastrointestinal surgery, etc., neurological diseases such as severe congenital heart disease, epilepsy, cerebral palsy, mental retardation, and exact inherited metabolic diseases, chromosomal diseases, genetic diseases, etc) 1 month before enrollment 6. Complicated with serious primary diseases of other vital organs or systems such as heart, liver, kidney and hematopoietic system; 7. Prior to screening, use of experimental drugs after birth, participation in other clinical studies 8. The probiotic products or formula containing bifidobacterium infantilum YLGB-1496 were taken one month before enrollment (for infants <1 month old, calculated from birth to enrollment) 9. Infants who had used immunosuppressive drugs (such as glucocorticoids and immunosuppressants) before enrollment 10. Infants and young children allergic to known probiotic product ingredients 11. Malnourished children requiring hospitalization 12. Other reasons that the investigator deems inappropriate to participate in the clinical trial, such as influencing efficacy evaluation or poor adherence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of allergy in children measured using data from hospital medical documents and records during the whole study course (total of 3 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Intestinal health status of infants (incidence of functional gastrointestinal diseases such as diarrhea and constipation and functional dyspepsia syndrome), measured using data from hospital medical documents and records during the whole study course (total of 3 months) 2. Incidence of upper respiratory tract infections in infants and young children (including frequency, duration, intensity, and medication), measured using data from hospital medical documents and records during the whole study course (total of 3 months) 3. Changes in the diversity and abundance of intestinal flora. Fecal samples will be collected to test the gut microbiome based on 16S rDNA information. Shannon, Simpson, Chao1, and ACE indices will be used as indicators of the alpha diversity. Principal coordinate analysis (PCoA), based on the Bray-Curtis distance, will be used to analyze the ß-diversity. LDA scores (>4.0) derived from the LEfSe analysis at genus and species levels will be used to identify several bacterial genera and species that differed in the two groups. Timepoints: before and after intervention 4. Growth and development of children: weight, length and head circumference of children measured before and after the intervention | — |
Countries
China
Contacts
Public ContactKe Chen
Outcome results
None listed