PrEggNut Study: protocol for a randomised controlled trial investigating the effect of a maternal diet rich in eggs and peanuts from <23 weeks' gestation during pregnancy to 4 months' lactation on infant IgE-mediated egg and peanut allergy outcomes

Debra J Palmer; Thomas R Sullivan; Dianne E Campbell; Ralph Nanan; Michael S Gold; Peter S Hsu; Merryn J Netting; Vicki McWilliam; Jennifer J Koplin; Kirsten P Perrett; Patrick Quinn; Michael O'Sullivan; Susan L Prescott; Rosalie Grivell; Maria Makrides

doi:10.1136/bmjopen-2021-056925

PrEggNut Study: protocol for a randomised controlled trial investigating the effect of a maternal diet rich in eggs and peanuts from <23 weeks' gestation during pregnancy to 4 months' lactation on infant IgE-mediated egg and peanut allergy outcomes

BMJ Open. 2022 Jun 13;12(6):e056925. doi: 10.1136/bmjopen-2021-056925.

Authors

Debra J Palmer^{1

2}, Thomas R Sullivan^{3

4}, Dianne E Campbell^{5

6}, Ralph Nanan^{7

8}, Michael S Gold^{9

10}, Peter S Hsu^{5

6}, Merryn J Netting^{3

11}, Vicki McWilliam^{12

13}, Jennifer J Koplin^{12

14}, Kirsten P Perrett^{13

14}, Patrick Quinn^{9

10}, Michael O'Sullivan^{15

16}, Susan L Prescott^{17

16}, Rosalie Grivell¹⁸, Maria Makrides^{3

9}

Affiliations

¹ Telethon Kids Institute, The University of Western Australia, Nedlands, Western Australia, Australia [email protected].
² UWA Medical School, The University of Western Australia, Perth, Western Australia, Australia.
³ SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.
⁴ School of Public Health, The University of Adelaide, Adelaide, South Australia, Australia.
⁵ Discipline of Child and Adolescent Health, The University of Sydney, Lidcombe, New South Wales, Australia.
⁶ Department of Allergy and Immunology; and Kids Research, The Children's Hospital at Westmead, Westmead, New South Wales, Australia.
⁷ Charles Perkins Center, The University of Sydney, Sydney, New South Wales, Australia.
⁸ Sydney Medical School Nepean, The University of Sydney, Sydney, New South Wales, Australia.
⁹ Faculty of Health and Medical Sciences, The University of Adelaide, Adelaide, South Australia, Australia.
¹⁰ Department of Allergy and Clinical Immunology, Women's and Children's Health Network, North Adelaide, South Australia, Australia.
¹¹ Department of Nutrition, Women's and Children's Health Network, North Adelaide, South Australia, Australia.
¹² Murdoch Childrens Research Institute, Parkville, Victoria, Australia.
¹³ Department of Allergy and Immunology, The Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.
¹⁴ Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia.
¹⁵ Faculty of Medicine Dentistry and Health Sciences, The University of Western Australia, Perth, Western Australia, Australia.
¹⁶ Immunology Department, Perth Children's Hospital, Nedlands, Western Australia, Australia.
¹⁷ Telethon Kids Institute, The University of Western Australia, Nedlands, Western Australia, Australia.
¹⁸ Department of Obstetrics Gynaecology and Reproductive Medicine, Flinders University, Bedford Park, South Australia, Australia.

Abstract

Introduction: Clinical studies supported by immunological data indicate early life intervention strategies to be promising in reducing the growing global burden of food allergies. The events that predispose to food allergy, including the induction of allergen-specific immune responses, appear to be initiated early in development. Early exposure to food allergens in utero and via breast milk is likely to be important in initiating oral tolerance. We aim to determine the effectiveness of higher maternal food allergen consumption during pregnancy and lactation on infant food allergy outcomes.

Methods and analysis: This is a multisite, parallel, two-arm (1:1 allocation), single-blinded (outcome assessors, statistical analyst and investigators), randomised controlled trial. Pregnant women (<23 weeks' gestation) whose (unborn) infants have at least two biological family members (mother, father or siblings) with medically diagnosed allergic disease are eligible to participate. After obtaining written informed consent, pregnant women are randomised to either a high egg and peanut diet (at least 6 eggs and 60 peanuts per week) or standard (low) egg and peanut diet (no more than 3 eggs and 30 peanuts per week). The women are asked to follow their allocated diet from <23 weeks' gestation to 4 months' lactation. The primary outcome is food challenge proven IgE-mediated egg and/or peanut allergy in the infants at 12 months of age. Key secondary outcomes include infant sensitisation to egg and/or peanut and infant eczema. Our target sample size is 2136 women. Analyses will be performed on an intention-to-treat basis according to a pre-specified statistical analysis plan.

Ethics and dissemination: Ethical approval has been granted from the Women's and Children's Health Network Human Research Ethics Committee (approval number HREC/18/WCHN/42). Trial results will be presented at scientific conferences and published in peer-reviewed journals.

Trial registration number: Australian New Zealand Clinical Trials Registry ACTRN12618000937213.

Keywords: IMMUNOLOGY; NUTRITION & DIETETICS; PERINATOLOGY; PREVENTIVE MEDICINE.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Allergens
Arachis
Australia
Child
Child Health
Diet
Egg Hypersensitivity*
Female
Food Hypersensitivity*
Humans
Immunoglobulin E
Infant
Lactation
Peanut Hypersensitivity* / prevention & control
Pregnancy
Randomized Controlled Trials as Topic
Women's Health

Substances

Allergens
Immunoglobulin E

Associated data

ANZCTR/ACTRN12618000937213