Atopic dermatitis
Conditions
Interventions
Intervention Group 2:Bifidobacterium longum subsp. infantis CCFM1269
Control Group 2:Breastfeeding
Control Group 1:Placebo\
Intervention Group 1:Bifidobacterium breve CCFM1078
Sponsors
Wuxi Maternity and Child Health Care Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 3 Years
Inclusion criteria
Inclusion criteria: 1. Healthy infants born full-term at 37-42 weeks of gestation, who are either formula-fed or exclusively breastfed, with a birth weight >=2500g and <4000g, regardless of sex. 2. The infant's mother has no diagnosed metabolic diseases such as diabetes mellitus, and no infectious diseases such as hepatitis B or HIV. 3. Aged 0-3 years at the time of enrollment. 4. An allergy risk score of =6 points calculated using the Infant and Young Child Allergy Risk Assessment Form (referencing the study on allergic symptoms and risk factors in infants and young children by the China CDC Maternal and Child Health Center). 5. The infant's parent or primary guardian consents to the collection of the infant's blood, urine, and stool samples during the study. 6. No clinically diagnosed allergic diseases (including but not limited to eczema, asthma, allergic proctocolitis, allergic rhinitis, hay fever, etc.) at the time of enrollment. 7. Enrolled and receiving regular health check-ups at the Child Healthcare Department of Wuxi Maternal and Child Health Care Hospital, and following the feeding advice and guidance provided by the child healthcare physicians.. 8. The family or primary guardian agrees not to provide the infant with any additional probiotic products (including infant formula containing probiotics) during the intervention period. 9. The guardian of the enrolled participant agrees to participate in this interventional study, provides written informed consent, and is able to understand and complete forms such as the infant diary as required.
Exclusion criteria
Exclusion criteria: 1. History of asphyxia at birth or a history of NICU hospitalization; 2. Birth defects or congenital abnormalities; 3. Maternal history of obstetric high-risk factors during pregnancy, such as hypertensive disorders of pregnancy, gestational diabetes, cholestasis of pregnancy, as well as a history of alcohol abuse or drug use; 4. Use of antibiotic medications within 2 weeks prior to enrollment; 5. Diseases confirmed within 1 month prior to enrollment that are known to affect infant growth and development (e.g., pneumonia, severe diarrhea, severe constipation, severe cow's milk protein allergy, malnutrition, gastrointestinal surgery; severe congenital heart disease, epilepsy, cerebral palsy, intellectual disability and other neurological disorders; confirmed inborn errors of metabolism, chromosomal disorders, genetic diseases, etc.); 6. Concurrent presence of other severe primary diseases affecting important organs or systems such as the heart, liver, kidneys, or hematopoietic system; 7. Use of investigational drugs or participation in other clinical studies after birth, prior to screening; 8. Use of probiotic products within one month prior to enrollment (for infants aged <1 month at enrollment, this period is calculated from birth to enrollment); 9. Use of immunosuppressive drugs (e.g., corticosteroids, immunosuppressants) prior to enrollment; 10. Known allergy to any component of the probiotic product; 11. Malnutrition requiring hospitalization; 12. Any other reason deemed by the investigator to make the infant unsuitable for participation in this clinical trial, such as conditions that may interfere with efficacy evaluation or poor expected compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical Growth Velocity;Incidence of Allergic Diseases; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fecal HBD2;IgE;TNF-a;IFN-?;IL-10;Fecal calprotectin;Bone Mineral Density;1,25-Dihydroxyvitamin D3;IL-4;Fecal microbiota; | — |
Countries
China
Contacts
Public ContactRenqiang Yu
Wuxi Maternity and Child Health Care Hospital
Outcome results
None listed