None listed
Conditions
Interventions
Others : Infants born via cesarean section are fed formula according to their assigned group for 2 months.
Control group: Formula without Bifidobacterium longum
Group 1: Formula containing approximat
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Infants aged 48 hours or less, born via cesarean section to mothers aged 18 to under 45 years 2. full-term infants with gestational age of 37 to 42 weeks 3. Infants who are capable of normal breastfeeding or formula feeding.
Exclusion criteria
Exclusion criteria: 1. At Registration If either parent is a minor, under the age of 18. 2. Drop-out During Follow-up: 1) Use of antibiotics for more than 1 week within one month after birth. 2) Treatment for perinatal severe conditions such as neonatal asphyxia, neonatal hypoglycemia, sepsis, or congenital infections after registration. 3) Loss of contact via phone or failure to visit. 4) If parents wishes to withdraw from the registration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the relative abundance (proportion, %) of Bifidobacterium longum in fecal microbiome analysis between the regular formula group and the probiotic-fortified formula group at 2 months of age | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence rate of atopic dermatitis at 2, 6, or 12 months of age ;Evaluation of atopic dermatitis severity using SCORAD (Scoring Atopic Dermatitis) at 2, 6, and 12 months of age;Measurement of transepidermal water loss (TEWL) at 2, 6, and 12 months of age;Measurement of total IgE and specific IgE levels (egg white, cow’s milk, wheat, walnut, peanut, Dermatophagoides pteronyssinus [DP], Dermatophagoides farinae [DF]) at 6, and 12 months of age;Measurement of serum cytokine and chemokine levels (interleukin [IL]-4, IL-5, IL-10, IL-12, IL-13, IL-17, IL-22, IL-31, IL-33, interferon-gamma [IFN-?], transforming growth factor-beta [TGF-ß], tumor necrosis factor-alpha [TNF-a], thymic stromal lymphopoietin [TSLP], C-C motif chemokine ligand 11 [CCL11, Eotaxin-1], CCL17 [TARC], CCL22 [MDC], CCL26 [Eotaxin-3], CCL27 [CTACK]) at 6, and 12 months of age;Subjective SCORAD scores (Scoring Atopic Dermatitis) between the regular formula group and the probiotic-fortified formula group at 2, 6, and 12 months of age;Objective SCORAD scores (Scoring Atopic Dermatitis) between the regular formula group and the probiotic-fortified formula group at 2, 6, and 12 months of age | — |
Countries
Korea, Republic of
Contacts
Public ContactYeonghee Kim
Samsung Medical Center
Outcome results
None listed