Allergic disease
Conditions
Interventions
intervention group:Bifidobacterium animalis subsp. lactis BLa80
control group:placebo
Breast feeding control group:No probiotic and placebo
Sponsors
Chengdu Women and Children's Central Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 3 Years
Inclusion criteria
Inclusion criteria: 1. Healthy children born at term of 37-42 weeks of pregnancy, artificially fed or exclusively breastfed, with a birth weight of 2500g or more but less than 4000g; 2. Mother has no diagnosed metabolic disorder infectious diseases during pregnancy; 3. Age at enrollment: 0-3 years old; 4. The allergy risk score calculated by the "Infant Allergy Risk Assessment Form" is >= 6 points; 5. Parents or primary guardians of children agree to collect fecal samples during this study; 6. No allergic diseases (including but not limited to eczema, asthma, allergic proctocolitis, allergic rhinitis, hay fever, etc.) diagnosed by clinicians at the time of enrollment; 7. Regular child health caring; 8. Family members or main guardians promise not to add additional probiotic products to children during the intervention period; 9. The guardian of the children agrees to participate in this intervention study and signs a written informed consent, and is able to understand and fill out forms such as infant diaries as required.
Exclusion criteria
Exclusion criteria: 1. Children with a history of suffocation or NICU hospitalization at birth; 2. Children have birth defects or congenital abnormalities; 3. Mother had pregnancy induced hypertension syndrome, eclampsia and pre-eclampsia, gestational diabetes, cholestasis of pregnancy and other obstetric risk factors, as well as a history of alcoholism and drug abuse during pregnancy; 4. Children who have 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 cow's milk protein allergy, malnutrition, gastrointestinal surgery, serious Congenital heart defect, epilepsy, cerebral palsy, mental retardation and other Nervous system disease, as well as exact genetic metabolic diseases, chromosome diseases, genetic diseases, etc.); 6. Severe primary diseases of other important organs or systems such as the heart, liver, kidney, and hematopoietic system in combination; 7. Prior to screening and after birth, experimental drugs were used and other clinical studies were conducted; 8. Children who have taken probiotic products one month before enrollment; 9. Infants who have used immunosuppressive drugs (such as glucocorticoids and Immunosuppressive drug) before enrollment; 10. Children who are allergic to known probiotic product ingredients; 11. Children with malnutrition who require hospitalization; 12. Other reasons that researchers believe are not suitable for participating in this clinical trial, such as affecting efficacy evaluation or poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of allergic diseases;fecal sIgA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fecal Calprotectin;gut microbiota analysis;fecal HBD2;fecal LL-37; | — |
Countries
China
Contacts
Public ContactChen Ke
Chengdu Women and Children's Central Hospital
Outcome results
None listed