Early introduction of allergenic foods to induce tolerance in infants

ISRCTN	ISRCTN14254740
DOI	https://doi.org/10.1186/ISRCTN14254740
Protocol serial number	FSA ref: T07051
Sponsors	Guy's and St Thomas' NHS Foundation Trust, King's College London (UK)
Funders	Food Standards Agency, Medical Research Council (UK)

Submission date: 06/02/2009
Registration date: 31/03/2009
Last edited: 16/12/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Gideon Lack
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised controlled multi-centre trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Randomised controlled trial of early introduction of allergenic foods to induce tolerance in infants
Study acronym	EAT (Enquiring About Tolerance)
Study objectives	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(s)	St Thomas' Hospital Research Ethics Committee, 20/10/2008, ref: 08/H0802/93
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	The period prevalence of IgE mediated food allergy to the six intervention foods between one and three years of age in both arms
Key secondary outcome measure(s)	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
Completion date	31/07/2014

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	2500
Key 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
Key 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)
Date of first enrolment	02/11/2009
Date of final enrolment	30/07/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

St Thomas' Hospital

London
SE1 7EH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	05/05/2016		Yes	No
Results article	results	06/08/2018		Yes	No
Other publications	Secondary analysis	07/12/2021	09/12/2021	Yes	No
Other publications	Defining the window of opportunity and the target populations to prevent peanut allergy	12/12/2022	16/12/2022	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

16/12/2022: Publication reference added.
09/12/2021: Publication reference added.
15/10/2018: The following changes have been made:
1. The recruitment start date has been changed from 02/02/2009 to 02/11/2009.
2. The recruitment end date has been changed from 31/07/2014 to 30/07/2012.
11/07/2018: Publication reference added.
07/03/2016: Publication reference added.