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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

QuEST Trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Egg allergy

Condition category

Condition code

Inflammatory and Immune System

Allergies

Diet and Nutrition

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]

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]

Breast milk ovalbumin and ovomucoid (egg) concentration measured by ELISA method.

Timepoint [1]

At 6 weeks of lactation.

Secondary outcome [1]

Breast milk egg-specific IgA and IgG concentration measured by ELISA method.

Timepoint [1]

At six weeks of lactation.

Secondary outcome [2]

Maternal serum ovalbumin and ovomucoid (egg) concentrations measured by ELISA methods.

Timepoint [2]

At six weeks of lactation.

Secondary outcome [3]

Maternal serum total IgG, egg-specific IgG4 and egg-specific IgA concentrations measured by ELISA methods.

Timepoint [3]

At six weeks of lactation.

Secondary outcome [4]

Infant serum ovalbumin and ovomucoid (egg) concentrations measured by ELISA methods.

Timepoint [4]

At six weeks of lactation.

Secondary outcome [5]

Infant serum total IgG, egg-specific IgG4 and egg-specific IgA concentrations measured by ELISA methods.

Timepoint [5]

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)

Recruitment hospital [1]

Princess Margaret Hospital - Subiaco

Recruitment postcode(s) [1]

6008 - Subiaco

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

GPO Box 1421 Canberra ACT 2601

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Princess Margaret Hospital Foundation

Address [2]

Princess Margaret Hospital for Children
Roberts Rd Subiaco WA 6008

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Princess Margaret Hospital for Children

Ethics committee address [1]

Princess Margaret Hospital for Children
Roberts Rd
Subiaco WA 6008

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

21/03/2013

Ethics approval number [1]

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

Dr Debbie Palmer

Address

Level 5 Admin Building
Princess Margaret Hospital
100 Roberts Road
Subiaco WA 6008

Country

Australia

Phone

+61 8 9340 8834

Fax

[email protected]

Contact person for public queries

Name

Debbie Palmer

Address

Level 5 Admin Building
Princess Margaret Hospital
100 Roberts Road
Subiaco WA 6008

Country

Australia

Phone

+61 8 9340 8834

Fax

[email protected]

Contact person for scientific queries

Name

Debbie Palmer

Address

Level 5 Admin Building
Princess Margaret Hospital
100 Roberts Road
Subiaco WA 6008

Country

Australia

Phone

+61 8 9340 8834

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Effects of maternal dietary egg intake during early lactation on human milk ovalbumin concentration: a randomized controlled trial.	2016	https://dx.doi.org/10.1111/cea.12806

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically