Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gideon Lack

ORCID ID

Contact details

Children's Allergies Department
2nd Floor
Stairwell B
South Wing
St Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FSA ref: T07051

Study information

Scientific title

Randomised controlled trial of early introduction of allergenic foods to induce tolerance in infants

Acronym

EAT (Enquiring About Tolerance)

Study hypothesis

1. The early introduction of allergenic foods (from three months of age) will induce regulatory mechanisms that result in a reduced level of food allergy by three years of age. The effect on food sensitisation at three years of age will be determined.
2. The early introduction (from three months of age) of allergenic foods into the infant's diet may lead to a reduction in the prevalence of other allergic conditions by three years of age: specifically asthma (including atopic wheeze), eczema, allergic rhinitis (including aero-allergen sensitisation) combined food allergy prevalence (including food sensitization) and the prevalence of combined allergic disease.
3. The early introduction of allergenic foods does not have any deleterious effects

Ethics approval

St Thomas' Hospital Research Ethics Committee, approved on 20/10/2008 (ref: 08/H0802/93)

Study design

Randomised controlled multi-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Food allergy, food hypersensitivity, eczema, asthma, allergic rhinitis

Intervention

The intervention arm consists of the dietetic controlled introduction of allergenic foods from three months of age. Baby rice mixed with breast milk or water will be commenced first, followed by cow's milk based yoghurt. Subsequently egg, wheat, sesame, fish and peanut will be sequentially introduced into the diet in high doses with each food being ingested 2 times a week achieving a total ingestion of 4 g or more per week of each food protein by five months of age.

Mothers will not introduce wheat before 4 months of age. Infants in the intervention arm will be required to consume the allergenic foods until the one-year assessment at which point ongoing consumption of all six allergenic foods will be encouraged until the end of the study when subsequent consumption will be a matter of parental choice.

The control arm will follow standard UK Government weaning advice (exclusive breast feeding until around 6 months of age) and no early introduction of allergenic foods (egg, wheat, peanuts, tree nuts, seeds, fish and shell fish) before six months of age.

Total duration of follow-up: Infant: from 3 months to 3 years of age

Joint/Secondary sponsor details:
King's College London
Room 1.8
Hodgkin Building, Guy's Campus
King's College London
London, SE1 1UL
United Kingdom

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The period prevalence of IgE mediated food allergy to the six intervention foods between one and three years of age in both arms

Secondary outcome measures

1. Period (one to three years of age) prevalence food outcomes:
1.1. The period prevalence of all IgE mediated food allergy between one and three years of age in both arms
1.2. The period prevalence of all food allergy (IgE and non-IgE mediated) between one and three years of age in both arms
1.3. The period prevalence of sensitisation to food between one and three years of age in both arms

2. Cumulative (by three years of age) prevalence food outcomes:
2.1. The cumulative prevalence of IgE mediated food allergy to the six intervention foods by three years of age.
2.2. The cumulative prevalence of all IgE mediated food allergy by three years of age
2.3. The cumulative prevalence of all food allergy (IgE and non-IgE mediated) by three years of age
2.4. The cumulative prevalence of non-IgE mediated food allergy by three years of age
2.5. The cumulative prevalence of sensitization to the six foods by three years of age

3. Other allergic disease outcomes:
3.1. The point prevalence of eczema at one year and three years of age and cumulative prevalence of eczema by three years of age
3.2. The severity of eczema at one year and three years of age by Severity Scoring of Atopic Dermatitis index (SCORAD) and Nottingham Eczema Severity Score (NESS)
3.3. The prevalence of allergic rhinitis at three years of age
3.4. The prevalence of inhalant allergen sensitisation at one year and at three years of age by skin prick test
3.5. The prevalence of inhalant allergen sensitisation at one year and at three years of age by specific IgE measurement
3.6. The prevalence of the atopic wheeze phenotype at three years of age

4. Composite allergy outcome:
4.1. The prevalence of combined allergic disease (a composite of cumulative IgE mediated food allergy to all foods, atopic wheeze phenotype, eczema and allergic rhinitis) at three years of age
4.2. The prevalence of combined allergic disease (a composite of cumulative IgE and non-IgE mediated food allergy to all foods, atopic wheeze phenotype, eczema and allergic rhinitis) at three years of age

Overall trial start date

02/02/2009

Overall trial end date

31/07/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pregnant mothers attending their 12/20 week ultrasound scans
2. Mothers planning on exclusively breast feeding for at least the first 3 months
3. Informed consent obtained from parent or guardian

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

3,000 pregnant women (2,500 infants)

Participant exclusion criteria

1. Significant antenatal anomaly at 20 week ultrasound scan
2. Multiple pregnancy
3. Significant congenital disease (enteropathy, congenital heart disease, renal disease)
4. Premature delivery (less than 37 completed weeks gestation)
5. Parents not planning on breast feeding exclusively for at least the first 3 months
6. Parents planning on moving away from London before their child is three years of age
7. Parents unable to speak and read English
8. Unwillingness or inability to comply with study requirements and procedures
9. Family intend infant to be on a restricted diet (any of the six intervention foods)

Recruitment start date

02/02/2009

Recruitment end date

31/07/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Children's Allergies Department
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Guy's and St Thomas' Foundation NHS Trust (UK)

Sponsor details

R&D Department
3rd Floor
Conybeare House
Great Maze Pond
London
SE1 9RT
United Kingdom

Sponsor type

Government

Website

http://www.guysandstthomas.nhs.uk/

Funders

Funder type

Not defined

Funder name

Food Standards Agency (UK) - Lead funder

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Editorial Notes