Early introduction of allergenic foods to induce tolerance in infants
| ISRCTN | ISRCTN14254740 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14254740 |
| Secondary identifying numbers | FSA ref: T07051 |
- 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
Scientific
Children's Allergies Department
2nd Floor, Stairwell B, South Wing
St Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
Study information
| Study design | Randomised controlled multi-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 study start date | 02/02/2009 |
| Completion date | 31/07/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 3,000 pregnant women (2,500 infants) |
| 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
- England
- United Kingdom
Study participating centre
St Thomas' Hospital
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Sponsor information
Guy's and St Thomas' NHS Foundation Trust
Hospital/treatment centre
Hospital/treatment centre
R&D Department
3rd Floor, Conybeare House
Great Maze Pond
London
SE1 9RT
England
United Kingdom
| Website | http://www.guysandstthomas.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/00j161312 |
King's College London (UK)
University/education
University/education
Room 1.8
Hodgkin Building, Guy's Campus
London
SE1 1UL
England
United Kingdom
Funders
Funder type
Government
Food Standards Agency
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- The Food Standards Agency, FSA
- Location
- United Kingdom
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
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.
