None listed
Conditions
Brief summary
Regular consumption of traditionally allergenic foods, like egg and peanut, in solid foods can reduce food allergies, however this is too late for some infants. This PrEggNut study will determine whether the risk of developing food allergies in infancy can be reduced by a maternal diet rich in eggs and peanuts during pregnancy and breastfeeding. The intervention period is from 22 weeks gestation in pregnancy until 4 months of breastfeeding. The infants are followed up until 12 months of age. The study design is a multi-site, randomised controlled trial. It is powered for infant egg and peanut food allergy outcomes with a sample size aim of 2136 women and their infants. The primary outcome for this study will be food challenge proven IgE-mediated egg and/or peanut allergy at 12 months of age. The key translatable message from this study will be to answer the question of whether higher maternal dietary intakes of eggs and peanuts during pregnancy and breastfeeding are needed to reduce the risk of food allergies developing in infants..
Interventions
The high egg and peanut diet group: Regular maternal consumption of at least 6 eggs and 60 peanuts per week from 22 weeks gestation during pregnancy until 4 months postnatal infant age while breastfeeding. Participating women will be able to include all forms of egg and peanut, and egg and peanut containing foods, towards their weekly target of egg and peanut ingestion. They will be provided with a conversion table showing the amount present in common egg or peanut foods, for example peanut butt
The high egg and peanut diet group: Regular maternal consumption of at least 6 eggs and 60 peanuts per week from 22 weeks gestation during pregnancy until 4 months postnatal infant age while breastfeeding. Participating women will be able to include all forms of egg and peanut, and egg and peanut containing foods, towards their weekly target of egg and peanut ingestion. They will be provided with a conversion table showing the amount present in common egg or peanut foods, for example peanut butter, or egg in quiche, meatballs or in baked goods like cake and muffins. Compliance: Participants will complete a four question quick (less than 5 minute) assessment of their egg and peanut intakes each month during the intervention period. This will be completed via a link sent to their mobile phone and used to assess intervention compliance. In the post-natal period, one additional question on breastfeeding status will also be collected each month along with the egg and peanut intake questions. These dietary group adherence assessments will cease at 4 months postpartum or prior if the participating woman ceases to breastfeed. The recruitment research assistants at each site who will be providing the individual face-to-face dietary group allocation advice to participants will be trained by CIA Dr Palmer, who will observe and monitor their intervention advice on a six monthly basis throughout the trial. The recruitment research assistants will not collect any outcome assessment data.
Sponsors
The Kids Research Institute Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Women who are able to give informed consent, with a singleton pregnancy of less than 23 weeks gestation and who are planning to breastfeed for at least 4 months. Fetus to have at least two family members (mother, father or siblings) with medically diagnosed allergic disease (asthma, eczema, hay-fever or IgE mediated food allergy).
Exclusion criteria
Women with egg or peanut allergies (<1% of adult population) will be excluded, as they would be unable to safely follow the intervention without an allergic reaction.
Outcome results
None listed