Please use this identifier to cite or link to this item:
https://hdl.handle.net/2440/135753
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Type: | Journal article |
Title: | 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 |
Author: | Palmer, D.J. Sullivan, T.R. Campbell, D.E. Nanan, R. Gold, M.S. Hsu, P.S. Netting, M.J. McWilliam, V. Koplin, J.J. Perrett, K.P. Quinn, P. O'Sullivan, M. Prescott, S.L. Grivell, R. Makrides, M. |
Citation: | BMJ Open, 2022; 12(6):e056925-1-e056925-8 |
Publisher: | BMJ |
Issue Date: | 2022 |
ISSN: | 2044-6055 2044-6055 |
Statement of Responsibility: | 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 |
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. |
Keywords: | Humans Food Hypersensitivity Egg Hypersensitivity Peanut Hypersensitivity Immunoglobulin E Allergens Diet Lactation Pregnancy Child Infant Women's Health Australia Female Randomized Controlled Trials as Topic Arachis Child Health |
Rights: | © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. |
DOI: | 10.1136/bmjopen-2021-056925 |
Grant ID: | http://purl.org/au-research/grants/nhmrc/1147576 http://purl.org/au-research/grants/nhmrc/1144544 http://purl.org/au-research/grants/nhmrc/1061704 http://purl.org/au-research/grants/nhmrc/1173576 http://purl.org/au-research/grants/nhmrc/1156518 http://purl.org/au-research/grants/nhmrc/1158699 |
Published version: | http://dx.doi.org/10.1136/bmjopen-2021-056925 |
Appears in Collections: | Obstetrics and Gynaecology publications |
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hdl_135753.pdf | Published version | 511.84 kB | Adobe PDF | View/Open |
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