Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000643774
Ethics application status
Approved
Date submitted
1/06/2013
Date registered
7/06/2013
Date last updated
7/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Questioning the role of egg in lactation for induction of specific tolerance: the QuEST trial.
Scientific title
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.

Secondary ID [1] 282606 0
Nil known
Universal Trial Number (UTN)
Trial acronym
QuEST Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Egg allergy 289299 0
Condition category
Condition code
Inflammatory and Immune System 289630 289630 0 0
Allergies
Diet and Nutrition 289631 289631 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 287276 0
Prevention
Comparator / control treatment
Control Group: There will be one control group, maternal dietary oral egg intake of an egg-free diet (Group 3, n=40) from randomisation between 36-39 weeks gestation until 6 weeks of lactation.
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.
Control group
Dose comparison

Outcomes
Primary outcome [1] 289718 0
Breast milk ovalbumin and ovomucoid (egg) concentration measured by ELISA method.
Timepoint [1] 289718 0
At 6 weeks of lactation.
Secondary outcome [1] 303102 0
Breast milk egg-specific IgA and IgG concentration measured by ELISA method.
Timepoint [1] 303102 0
At six weeks of lactation.
Secondary outcome [2] 303103 0
Maternal serum ovalbumin and ovomucoid (egg) concentrations measured by ELISA methods.
Timepoint [2] 303103 0
At six weeks of lactation.
Secondary outcome [3] 303187 0
Maternal serum total IgG, egg-specific IgG4 and egg-specific IgA concentrations measured by ELISA methods.
Timepoint [3] 303187 0
At six weeks of lactation.
Secondary outcome [4] 303188 0
Infant serum ovalbumin and ovomucoid (egg) concentrations measured by ELISA methods.
Timepoint [4] 303188 0
At six weeks of lactation.
Secondary outcome [5] 303190 0
Infant serum total IgG, egg-specific IgG4 and egg-specific IgA concentrations measured by ELISA methods.
Timepoint [5] 303190 0
At six weeks of lactation.

Eligibility
Key inclusion criteria
Inclusion criteria:
- Women who have a history of allergic disease (asthma, eczema, allergic rhinitis, IgE mediated food allergy)
- Women planning to breastfeed
Minimum age
16 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:
- Women who have an egg allergy
- Women who have a non-singleton pregnancy

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Written informed consent will be obtained. Each eligible woman will be randomised to one of three groups and assigned a unique study number according to a randomisation schedule. The allocation will be concealed by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be computer-generated (varying size of permuted blocks). The randomisation schedule will be produced by an independent party.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
The expected rate of detection of egg protein in breast milk in women regularly consuming egg in their diet is at least 46%, compared to a detection rate of 6-7% in women following an egg free diet during lactation. This is based on our previous RCT studies of egg protein content of breast milk. To detect an increase in egg protein content of breast milk from 7% to 46%, absolute increase of 39%, relative increase of 85% (with 90% power, alpha-value 0.025 due to the three group design), we require 32 infants per group. To allow for any residual imbalance between the groups, even after randomisation, and to take into account of potential confounders (maternal age, dietary factors) in the analysis we have inflated our sample size by 20%, as well as a further 5% for loss to follow-up or withdrawal, hence we will recruit a total of 40 women per group into the trial.
Analysis Plan: We will perform between group comparisons for each primary and secondary outcome after the intervention period at 6 weeks of lactation, using Student t-tests or the Mann-Whitney U test if the data do not meet the assumptions for parametric tests and cannot be normalized by using logarithmic transformation. Repeated measures ANOVA will be used for the cytokine trajectory analysis. A significance threshold of 0.05 will be used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/06/2013
Actual
7/08/2013
Date of last participant enrolment
Anticipated
Actual
27/11/2014
Date of last data collection
Anticipated
8/12/2017
Actual
29/11/2017
Sample size
Target
120
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 1073 0
Princess Margaret Hospital - Subiaco
Recruitment postcode(s) [1] 6932 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 287388 0
Government body
Name [1] 287388 0
National Health and Medical Research Council
Country [1] 287388 0
Australia
Funding source category [2] 287389 0
Charities/Societies/Foundations
Name [2] 287389 0
Princess Margaret Hospital Foundation
Country [2] 287389 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
Department of Paediatrics and Child Health
University of Western Australia
Roberts Rd
Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 286133 0
None
Name [1] 286133 0
Address [1] 286133 0
Country [1] 286133 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289360 0
Princess Margaret Hospital for Children
Ethics committee address [1] 289360 0
Princess Margaret Hospital for Children
Roberts Rd
Subiaco WA 6008
Ethics committee country [1] 289360 0
Australia
Date submitted for ethics approval [1] 289360 0
Approval date [1] 289360 0
21/03/2013
Ethics approval number [1] 289360 0
2060/EP

Summary
Brief 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.
Trial website
Trial related presentations / publications
JR Metcalfe, JA Marsh, N D’Vaz, DT Geddes, CT Lai, SL Prescott, DJ Palmer. Effects of maternal dietary egg intake during early lactation on human milk ovalbumin concentration: a randomized controlled trial. Clin Exp Allergy 2016;46(12):1605-13
Public notes

Contacts
Principal investigator
Name 40470 0
Dr Debbie Palmer
Address 40470 0
Level 5 Admin Building
Princess Margaret Hospital
100 Roberts Road
Subiaco WA 6008
Country 40470 0
Australia
Phone 40470 0
+61 8 9340 8834
Fax 40470 0
Email 40470 0
[email protected]
Contact person for public queries
Name 40471 0
Dr Debbie Palmer
Address 40471 0
Level 5 Admin Building
Princess Margaret Hospital
100 Roberts Road
Subiaco WA 6008
Country 40471 0
Australia
Phone 40471 0
+61 8 9340 8834
Fax 40471 0
Email 40471 0
[email protected]
Contact person for scientific queries
Name 40472 0
Dr Debbie Palmer
Address 40472 0
Level 5 Admin Building
Princess Margaret Hospital
100 Roberts Road
Subiaco WA 6008
Country 40472 0
Australia
Phone 40472 0
+61 8 9340 8834
Fax 40472 0
Email 40472 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of maternal dietary egg intake during early lactation on human milk ovalbumin concentration: a randomized controlled trial.2016https://dx.doi.org/10.1111/cea.12806
N.B. These documents automatically identified may not have been verified by the study sponsor.