Food allergy Food allergy
Conditions
Interventions
Pregnant women are administered one packet of synbiotic or placebo daily from week 34-35 of gestation to day 5 postpartum, and newborns are administered one packet of synbiotic or placebo daily the fi
Sponsors
Yanagida Noriyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Pregnant women over 18 years of age, between 22 to 34 weeks of pregnancy 2.The pregnant woman or her partner or a sibling has one or more of the following allergic diseases ;atopic dermatitis, bronchial asthma, food allergy, allergic rhinitis, allergic conjunctivitis. 3.Day 1 child born to a pregnant woman meeting 1.2 criteria above.
Exclusion criteria
Exclusion criteria: 1. Having difficulty ingesting synbiotics due to an existing medical condition 2. When a physician determines the patient has difficulty in participating in the study. 3. Multiple pregnancies 4. Having participated in this study at the time of previous pregnancy 5. Underlying medical conditions that were identified prenatally or postnatally that would make it difficult to administer synbiotics (cardiac disease, neuromuscular disease, hematological disease, gastrointestinal disease, bone system disease/endocrine/metabolic disease, immunological/allergic disease, diseases of the skin, eye and appendages, congenital malformations, chromosomal abnormalities). 6. Birth weight less than 2300g 7. Preterm (less than 37 weeks of gestation) or Post term (42 weeks or more of gestation) 8. Severe neonatal distress (Apgar score<4) 9. Physician has determined that it is difficult to perform the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of patients who developed food allergy with hens' egg or cow's milk or wheat at 12 months of age | — |
Secondary
| Measure | Time frame |
|---|---|
| Molecular systematics analysis and alpha and beta diversity based on 16S rRNA genes in the stool of mothers at 30-34 weeks gestation and during postpartum hospitalization (1-5 days postpartum), and breast milk of mothers during postpartum hospitalization (1-5 days postpartum), and at 1 month postpartum. Molecular systematics analysis and alpha and beta diversity based on 16S rRNA genes in the stool of infants at 3-5 days of age, 1 month, 4 months, and 12 months of age, and skin of infants at 3-5 days of age, and 1 month of age Rate of patients with sensitization to egg white, milk, wheat, peanut, walnut, and cashew nut at 12 months of age Specific IgE levels, blood short-chain fatty acid levels, IgA levels at stool, EASI score, and TEWL scores at 4 and 12 months of age Results of oral food challenge and provoked allergic symptoms due to the consumption of egg, milk or wheat until the infants were 12 months old Rate of infants with food allergy at 12 months of age after classifying by mode of delivery, antibiotic use, nutritional methods for children, and environmental factors Rate of patients with food allergy at 12 months of age after stratification by skin condition and presence of atopic dermatitis Impact of interventions on the development of food allergy by patient background factors (secondary analysis) Rate of patients with severe infectious diseases requiring hospitalization from birth to 12 months of age Rate of patients with food allergy and sensitization by the duration of administration of synbiotics to children Rate of patients with atopic dermatitis, bronchial asthma, allergic rhinitis, and food allergy at 24 and 36 months of age | — |
Contacts
Public ContactYoko Miura
National Hospital Organization Sagamihara National Hospital
Outcome results
None listed