Mother and child at risk for atopy
Conditions
Interventions
From admission for delivery through discharge (4 to 6 days postpartum), intervention group mothers received hospital meals excluding processed meat and processed fish and shellfish products, commercia
less energy from added animal fats and from sugars and sweeteners
a lower percentage of energy from fat (18.0% vs. 23.8%)
and a higher polyunsaturated-to-saturated fatty acid ratio (0.80 vs. 0.54). After discharge, mothers were instructed to continue restrictions on processed meat, processed fish and shellfish products,
when supplemental feeding was needed, elemental formula rather than cow'
s milk formula was provided, based on findings from the ABC trial. After discharge, cow'
s milk formula could be used when supplemental feeding was needed. Mothers completed a daily food diary from discharge through 1 month postpartum.
Control group mothers received the standard hospital
s milk formula was provided, based on findings from the ABC trial. After discharge, mothers were instructed to follow their usual diets without restriction, and cow'
s milk formula could be used when supplemental feeding was needed. Mothers completed the same daily food diary from discharge through 1 month postpartum.
Sponsors
The Jikei University School of Medicine
Ezaki Glico Co., Ltd. (collaborating organization for gut microbiome and breast-milk analyses
no financial support or role in clinical-outcome analysis)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Be in high-risk group of atopic sensitization: at least one of father, mother, brothers and sisters of infants has atopic diseases (asthma, atopic dermatitis, food allergy, allergic rhinitis, pollen allergy, allergic conjunctivitis) in past or as current status. 2. Participants who understand randomization into two groups either restricting processed meat group or non-restricting group 3. Be available to visit outpatient clinic by 2 years of age. 4. Be available to respond to questionnaires asking health conditions, e.g., doctor diagnosed asthma, by 5 years of age 5. Living in Tokyo and available to visit mother and child center outpatient clinic of Jikei University Hospital. 6. When the infant is suspected to be food allergy and other allergy, he or she can visit outpatient clinic for allergic disease at Jikei University Hospital to take care by specialists for allergy.
Exclusion criteria
Exclusion criteria: 1. Participating pregnant women have fool allergy to egg, nuts, meat, milk 2. Less than 36 weeks of gestational age 3. Breastfeeding is unavailable by medical reasons 4. Having serious conditions needing admission to NICU 5. Having some conditions needing admission to GCU and charged pediatrician judged the infant hard to participate in this trial 6. Having difficulty in communication with mother
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative incidence of clinically diagnosed immediate-type food allergy through 24 months of age, including anaphylaxis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory neurodevelopmental outcomes: M-CHAT at 18 months; CBCL at 18 and 24 months; CARS2 at 24 months; and ASD and ADHD diagnoses confirmed by 36 months after evaluation prompted by a positive screening result or other developmental concern documented by 24 months. Between-group comparisons were exploratory because no confirmatory testing hierarchy or multiplicity-adjustment procedure had been prespecified. | — |
Countries
Japan
Contacts
Public ContactHaruka Wada
The Jikei University School of Medicine Molecular Epidemiology
Outcome results
None listed