CompletedPhase 2ACTRN12613000643774

Questioning the role of egg in lactation for induction of specific tolerance: the QuEST trial.

In breastfeeding mothers with a history of allergic disease, the effects of maternal dietary egg intake, no egg compared to low or high egg intakes, during the first 6 weeks of lactation on the outcome of breast milk egg (ovalbumin and ovomucoid) concentrations.


Sponsor

University of Western Australia

Enrollment

120 participants

Start Date

Aug 7, 2013

Study Type

Interventional

Conditions

Summary

With increasing rates of food allergy in countries such as Australia, there is a growing need to understand the role and effects of early food allergen exposure in the development of tolerance to food allergens. Egg allergy is now the most common food allergy in babies in Australia, with almost 1 in 10 babies at 1 year of age in the community now having an egg allergy. Previous recommendations to prevent food allergy through early allergen avoidance of certain foods have failed and now have instead been associated with increased risk of allergy development. With rates of food allergies increasing in our young Australian children, prevention is therefore the key to reduce allergies and the associated burden on the individual, the family and the health care system. In recent studies we have found a significant number of babies to have food allergy reactions the first time they eat a solid food (for example, egg) at 4-6 months of age. This indicates that earlier strategies may be needed in some babies to prevent food allergy. To develop tolerance (and not have a food allergy reaction) to a food it is currently thought that regular eating of that food is needed. However the ideal age to eat the food and amount of the food is unknown. Foods proteins are known to pass from the breastfeeding mother’s diet into breast milk. Current thinking is that the regular presence of food proteins in breast milk will help babies to develop tolerance and hence prevent allergies to foods. The primary aim of the study is to investigate the effect of a breastfeeding mother’s dietary egg intake on egg levels in breast milk during the first six weeks of breastfeeding. We will recruit women with singleton pregnancies who have a history of allergic disease, and ask the women to eat "high egg" (4-6 eggs per week), "low egg" (1-3 eggs per week) or "egg-free" diet during the first 6 weeks of breastfeeding. Differences in egg levels in breast milk samples will be measured. The study will not interfere in any way with breastfeeding or the mother’s or the baby’s nutrition. With expanding the research in this area, recommendations of what women should eat while breastfeeding can be more evidence based, especially with the goal to reduce the current rising problem of food allergy in Australia.


Eligibility

Sex: FemalesMin Age: 16 YearssMax Age: 50 Yearss

Inclusion Criteria2

  • Women who have a history of allergic disease (asthma, eczema, allergic rhinitis, IgE mediated food allergy)
  • Women planning to breastfeed

Exclusion Criteria2

  • Women who have an egg allergy
  • Women who have a non-singleton pregnancy

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Interventions

Intervention Groups: There will be two intervention groups, maternal dietary oral egg intake of "high egg" 4-6 eggs per week (Group 1, n=40) or "low egg" 1-3 eggs per week (Group 2, n=40) from randomi

Intervention Groups: There will be two intervention groups, maternal dietary oral egg intake of "high egg" 4-6 eggs per week (Group 1, n=40) or "low egg" 1-3 eggs per week (Group 2, n=40) from randomisation between 36-39 weeks gestation until 6 weeks of lactation. The eggs can be prepared by any cooking method and includes egg as an ingredient in foods, for example quiche, egg custard. Compliance will be assessed by a diary card, phone calls at 2 and 4 weeks of lactation and at an appointment at 6 weeks of lactation.


Locations(1)

Princess Margaret Hospital - Subiaco

WA, Australia

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ACTRN12613000643774