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, 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
Intervention type
Behavioural
Phase
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
St Thomas' Hospital
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/
Organisation
King's College London (UK)
Sponsor details
Room 1.8
Hodgkin Building
Guy's Campus
London
SE1 1UL
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Not defined
Funder name
Food Standards Agency
Alternative name(s)
FSA
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26943128